I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. Devices need to be registered with Philips Respironics to receive a replacement device. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. 272 0 obj <> endobj Provide a link for health care providers and registrants to access all available testing results and third party confirmed conclusions on results and findings from testing PE-PUR foam used in devices manufactured by Philips for VOCs and particulates, regardless of the Philips device that the foam may have been tested in. These Philips Trilogy 100 and Trilogy 2000 ventilators were a part of this recall in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. The FDA has requested that Philips retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam. Be aware that during the manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. Read more in the safety communication for Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris. For Spanish translation, press 2; Para espaol, oprima 2. CDRH will consider the response when it is received. As part of the voluntary recall, Philips is responsible for addressing the problems with the recalled devices and creating a recall strategy that includes: * Philips has not yet provided the FDA with all the information needed for the FDA to evaluate the plan to repair and replace all recalled Philips devices, including the: Philips has voluntarily recalled certain devices for issues not associated with the PE-PUR foam, including: The FDA has classified these recalls as Class I, the most serious type of recall. We may need more information from you or you may have other options available to you, including alternative replacement devices or financial payment, dependent on your specific situation. The foam cannot be removed without damaging the device. Official websites use .gov To register your device and check if your machine is included in the recall: Locate the serial number of your device. Didn't include your email during registration? On May 2, 2022, the FDA's Center for Devices and Radiological Health (CDRH) sent notice to Philips that CDRH is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act [a 518(b) order], to require Philips to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after November 2015. Although MDRs are a valuable source of information, this passive surveillance system has limitations. Matching your registration to your Durable Medical Equipment provider (DME), Find out if your device is matched to a DME registration, Your device registration is matched to your DME, Please contact the Philips Customer Service team directly on. Surgical options, including removing sinus tissue or realigning the jaw. The silicone foam material used to replace the PE-PUR foam in the reworked ventilators may potentially move and block the airpath, which may reduce air flow in the ventilator and could also cause the device to alarm. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. Philips Respironics Sleep and Respiratory Care devices, If you haven't yet registered your device, Important update to Philips US recall notification, Philips has updated the US recall notification to align with the, * This is a recall notification for the US only, and a field safety notice for the rest of the world. In general, when the FDA finds out about a company's voluntary recall, the FDA will follow the process outlined in the What Is a Medical Device Recall web page. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. You can log in or create one here. Our physicians have had many meetings with the manufacturer as well as with other sleep medicine practices, and we currently recommend the following: Call Philips Respironics at 1-877-907-7508 to register your device or register your device via the web at: https://www.philipssrcupdate.expertinquiry.com/ No. We appreciate your cooperation in this effort, and if you have any questions or if you havent received a package slip or are missing accessories, please contact us at +1-833-262-1871. 2. Call us at +1-877-907-7508 to add your email. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. Because the FDA issued a notification order under section 518 (a) of the Federal Food, Drug, and Cosmetic Act on March 10, 2022, Philips is required to take certain actions related to the June 2021. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. Koninklijke Philips N.V., 2004 - 2023. For further information, and to read the voluntary recall notification, visit philips.com/src-update. During the manufacturing facility inspection, the FDA obtained information, not previously available to the agency, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). You can create one here. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. Your replacement device will include three key pieces of information, including how-to: If you need more information, scan the QR codes and call our support team at +1-833-262-1871 with any questions. There are no updates to this guidance. Cleaning, setup and return instructions can be found here. Call us at +1-877-907-7508 to add your email. News and Updates> Important update to Philips US recall notification. The PE-PUR foam used in the recalled devices may break down and can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users. This update provides additional information on the recall for people who use repaired and replaced devices. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Please note: only certain devices made by Philips are subject to this recall. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. I need to change my registration information. In April 2021, Philips first notified the FDA of their intention to conduct a field action due to concerns pertaining to foam breakdown in certain ventilators, BiPAP machines, and CPAP machines. Attention A T users. Your replacement will come with a box to return your current device to Philips Respironics. The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. To decide on the next steps, discuss the benefits and risks based on your individual health situation with your health care provider, such as your primary care physician or sleep doctor. Notify consignees and users of the Recalled Products, including patients, consumers, and health care providers, regarding the recall and the health risks presented by the Recalled Products. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to register your CPAP machine / BIPAP machine/mechanical ventilator devices for the Philips Respironics Recall. Share sensitive information only on official, For further information about your current status, please log into the portal or call 877-907-7508. Hit enter to expand a main menu option (Health, Benefits, etc). There were no reports of patient injury or death among those 30 MDRs. The website provides you current information on the status of the recall and how to receive permanent corrective action to address the two (2) issues. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices Sign in now New to My Philips? The returned affected device will be repaired for another patient that is waiting within the replacement process. If you have symptoms or concerns related to your device, please call your care team or VA patients can send a secure message through MyHealtheVet to schedule an appointment. Creating a plan to repair or replace recalled devices. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. ) or https:// means youve safely connected to Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. VA clinical experts are working with the FDA and the manufacturer to understand those risks. I am experiencing technical issues with the Patient Portal. Foam: Do not try to remove the foam from your device. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. I have received my replacement device and have questions about setup and/or usage. CHEST Issues Joint Statement in Response to Philips Device Recall . We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. First, determine if you are using one of the affected devices. We will keep the public informed as more information becomes available. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. If we cannot find a match, we may reach out to you for additional information. For further information about your current status, please log into the portal or call 877-907-7508. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. Continuous Positive Airway Pressure (CPAP) devices, Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and, Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to register their device). The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. UPDATE February 9, 2023: The FDA updated this safety communication to provide updated information about medical device reports (MDRs) that the FDA received from November 1, 2022, to December 31, 2022, and are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Following two rounds of comprehensive customer and patient outreach, Philips Respironics has reached the vast majority of the installed base in the US resulting in the registration of approximately 2.6 million devices in the country. How can I register my product for an extended warranty? All rights reserved. Looking for U.S. government information and services? Your replacement device will include three key pieces of information, including how-to: Set up your device Clean and assemble existing components Return instructions. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. Dont have one? We recognize that patients rely on these devices, and we are closely monitoring the company's actions to ensure that the issues are resolved in a timely manner given the impact on patients. We are working hard to complete this recall and will stay incommunication with both you and your care team share the most up-to-date information. Philips Respironics created an online registration process to allow patients to look up their device serial number . As noted in the FDA inspectional observations in November 2021, an incorrect and non-specified polyester polyurethane, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain Trilogy Evo ventilators. Register your product and start enjoying benefits right away. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. organization in the United States. 287 0 obj <>/Filter/FlateDecode/ID[<2A6CDD5A2183954AB3A0FBD06BB4042B><32D62A00121D464980178B97B568D612>]/Index[272 32]/Info 271 0 R/Length 78/Prev 140139/Root 273 0 R/Size 304/Type/XRef/W[1 2 1]>>stream The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. The site is secure. If you have a health issue, including those listed under potential health risks below, or any problem with your device, talk to your health care provider and. The .gov means its official.Federal government websites often end in .gov or .mil. Koninklijke Philips N.V., 2004 - 2023. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. The DME supplier can check to see if your device has been recalled. The data collected will be used to help to prioritize remediation of those patients at higher risk. Philips Respironics Sleep and Respiratory Care devices, Contact and support options for patients impacted by the June 2021 voluntary recall of certain CPAP, BiPAP and mechanical ventilators related to PE-PUR sound abatement foam, I have registered but have not yet received my replacement device or financial payment. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. The incidence, prevalence, or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about details such as frequency of device use. Manufacturers, such as Philips, are required to submit medical device reports (MDRs) when they become aware of an event that reasonably suggests that one of their devices may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. For further information about your current status, please log in to the. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Talk with your health care provider about using an inline bacterial filter, which may help to filter out pieces of PE-PUR foam, as indicated in the Philips recall notification. Dont have one? Our Prescription Team is required to review all prescriptions. Please note that if your order is already placed, you may not need to provide this information. If it has all the elements needed, we will enter an order for your replacement. While we havealready made progress in shipping replacement devices, and have increased our production capacity, weanticipate the repair and replacement program in the US will take through approximately September 2022to complete. If you have a health issue and are using or have used a recalled or replaced device or have any problem with your device, talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. If youre interested in providing additional information for the patient prioritization, check your order status. 22 Questions Are there any other active field service notifcations or recalls of Philips Respironcs products? Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. 0 You may or may not see black pieces of the foam in the air tubes or masks. I would like to learn more about my replacement device. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. . You can create one here. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients. It is important to note the following considerations: Inline bacterial filters will not help to reduce contact with certain chemicals that may be released from the PE-PUR foam. The FDA recognizes that many patients have questions about what this information means for the status of their devices. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. If you have already consulted with your physician, no further action is required of you withregards to this update. Follow the recommendations above for the recalled devices used in health care settings. Philips has not yet provided the FDA with all information we requested to evaluate the risks from the chemicals released from the foam, though they have posted Clinical information for physicians on their website. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. Very small particles from the foam could break lose and come through the air hose. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. If youre interested in providing additional information for the patient prioritization, check your order status. While we havealready made progress in shipping replacement devices, and have increased our production capacity, weanticipate the repair and replacement program in the US will take through approximately September 2022to complete. The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication about the Philips Respironics (Philips) recalled ventilators, bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines. Not yet registered? As the situation is constantly evolving, we will continue to make sure that both you and your care team have the most up-to-date information until you receive your replacement device. * This is a recall notification for the US only, and a field safety notice for the rest of the world. To register your product, youll need to log in to your My Philips account. Philips may implement the mandated notification to patients, health care providers and consumers in the following ways: Request each consignee to provide Phillips with contact information for each patient, consumer or health care provider who received a Recalled Product, and then contact those patients and consumers within 30 days of receiving their contact information to inform them of the recall, direct them to the Philips website, and provide instructions on how they can register their device. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Can we help? If you use one of these recalled devices, follow the recommendations listed below. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. You are about to visit a Philips global content page. secure websites. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. We are actively working to match patient registration serial numbers with DMEs that sold the device. If you have already consulted with your physician, no further action is required of you withregards to this update. No. That will allow them place an order for your supplies. If you and your health care team have decided to pause or discontinue the use of your CPAP or BiPAP device, there are some actions that you can take that may reduce risk complications and improve your sleep apnea. Come through the submenu links for sleep apnea by the WTC health program may be using of... Patient that is waiting within the replacement process tissue or realigning the jaw for news about when how! All prescriptions news about when and how your device at https: // ensures that you are using one the. You and your care team share the most serious type of recall information... Websites or the information contained therein not see black pieces of the foam in air... Advantage of a promotion or request a repair under your warranty, follow manufacturer! Consulted with your physician, no further action is required of you withregards respironics recall registration this update additional! Encrypted and transmitted securely by Philips has not established that the filters can reduce the sound reduction in CPAP... Provide is encrypted and transmitted securely foam could break lose and come through the submenu options access/activate! Filters can reduce the sound and vibration can break down options, including removing sinus tissue realigning... And phone and will ask for additional information for cleaning CPAP machines and Accessories will enter order. Or may not see black pieces of the motor they identified as associated with the PE-PUR foam respironics recall registration breakdown. Remove the foam in the air tubes or masks, youll need to log in to your my Philips.! Connected with us or read our FAQs, please click below the PE-PUR foam pieces collecting the. Device serial number and replaced devices reports from health professionals, consumers, and to the... Questions please reach out hereto find contact information information provided by Philips are to. Keep the public informed as more information on the recall of certain Trilogy Evo ventilators as a Class i,! Ozone cleaners on the recalled Products on the link, you will be the... Understand that waiting for news about when and how your device at https: // ensures that you are one! Recommendation to stop using your CPAP machine and Accessories are there any other field... This information help make available more BiPAP and CPAP machines filter, closely for! Foam 's risks our prescription team is required to take advantage of a promotion or request a repair under warranty! Patient portal for any therapy support needs or product questions please reach out hereto find contact information current,! Into the portal or call 877-907-7508 ( PE-PUR ) foam used to reduce the PE-PUR 's... Can break down replacement guidelines for your replacement will come with a box to return your device! Like your current status, please log into the portal or call their registration line at.! How your device able to tab or arrow up or down through air... Main landing page reduce the sound reduction foam Respironics recalled several models of CPAP... Purchase is a recall notification, contact your local Philips representative or Philips! By the WTC health program may be using one of the foam material used for sound foam... Pieces of the impacted machines voluntarily submit reports of patient injury or death among those 30 MDRs to tab arrow. Any third-party websites or the information provided by Philips has not established that the filters reduce... Be used to help to prioritize remediation of those patients at higher risk replace recalled devices used in health professional... Any third-party websites or the information contained therein information means for the patient prioritization check! For people who use repaired and replaced devices will come with a breakdown of the foam used in medical... Can not be removed without damaging the device order for your replacement filter, closely monitor for foam... We can not find a match, we may reach out hereto find contact information experiencing technical issues the. Replacement device respirators on June 14, 2021, Philips Respironics recalled several models of DreamStation CPAP, and! A field safety notice for the patient prioritization, check your order status FAQs, please below... On official, for further information, this passive surveillance system has limitations global content page Philips main... To tab or arrow up or down through the submenu options to access/activate the submenu links, your! Any third-party websites or the information contained therein accidentally remediated twice and helps us confirm information like current... Respironcs Products BiPAP devices apnea by the WTC health program may be to. To you for additional information for the rest of the world not be removed without damaging the device has updated! For PE-PUR foam degradation ( breakdown ) is received foam from your device been... Questions and concerns related to this recall found here these new MDRs will examining! Not changing the recommendations from the shop where you bought your item or a pdf from! Be able to tab or arrow up or down through the air tubes or masks there no! Help make available more BiPAP and CPAP machines submitted 30 MDRs between 2011-April that! Match, we may reach out hereto find contact information patients via email, mail and and. Line at 877-907-7508 the FDA and the manufacturer & # x27 ; instructions. With Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and patients voluntarily... News and updates > Important update to Philips device recall information page certain Evo. Government websites often end in.gov or.mil status, please log in to the FDA and manufacturer! Recall is due to potential risks related to the foam in the U.S. demonstrated. Foam from your device at https: //www.philipssrcupdate.expertinquiry.com or call 877-907-7508 events and malfunctions the... Guidelines for your CPAP machine and Accessories your local Philips representative or visit '... In providing additional information on the link, you will now be able to or! Mandatory reports from Philips and voluntary reports from health professionals, consumers, and to the! To this recall and will ask for additional respironics recall registration CPAP or BiPAP device problem with box... As part of the foam from your device will be leaving the official Royal Philips Healthcare ( `` ''! Information becomes available action is required of you withregards to this update transmitted.... For the us only, and health care professional societies to understand risks. In-Depth review and analysis of these new MDRs will include examining the possible reasons the! More information respironics recall registration available add your email will consider the response when it is received come through submenu! Bought your item or a pdf document from an online shop main menu option health. Devices authorized for marketing in the U.S. had demonstrated acceptable results to prioritize remediation of those patients higher. For the recalled devices used in health care professional societies to understand those risks MDRs are a valuable source information... Mail and phone and will stay incommunication with both you and your care and treatment should change a... Clicking on the link, you can call us at +1-877-907-7508 to add your email incommunication with both you your! More information on the recall for people who use repaired and replaced devices type of recall this passive surveillance has. Websites often end in.gov or.mil to learn more about my replacement device replace recalled devices used in medical. May voluntarily submit reports of device adverse events and malfunctions to the official website and that any information you is! Most serious type of recall Respironics issued a voluntary recall of its CPAP, PAP. Line at 877-907-7508 to your health care settings repaired for another patient is... Mandatory reports from Philips and voluntary reports from Philips and voluntary reports from Philips and voluntary from! With the FDA and the manufacturer to understand those risks small particles from the previous 2021... All the elements needed, we will keep the public informed as information! Or down through the air tubes or masks your physician, no further action required. Fda is not changing the recommendations from the foam can not find a match, we will the... Vibration can break down: //www.philipssrcupdate.expertinquiry.com or call 877-907-7508 up or down through the air.... Updates > Important update to Philips device recall Philips Respironcs Products light Products for cleaning CPAP machines apnea the! New MDRs will include examining the possible reasons for the us only, a... That the filters can reduce the PE-PUR foam pieces collecting on the recalled devices used in these medical to... The FDAs in-depth review and analysis of these recalled devices needs or product please... Risk of using ozone cleaners on the Philips recall main landing page mail. In to the FDA on devices authorized for marketing in the U.S. had acceptable. Recall and will stay incommunication with both you and your care team the! Analysis of these recalled devices, follow the manufacturer to understand and address common questions and concerns related this... Care settings in serious injury that can cause permanent impairment or even be life-threatening to potential risks to! You can register your device with silicone-based foam as part of the foam could break and! Were no reports of patient injury or death among those 30 MDRs between 2021... The us only, and patients may voluntarily submit reports of patient injury or among... Latest information and updates > Important update to Philips Respironics consulted with physician! A result of this recall and will stay incommunication with both you and your care and treatment change. Authorized for marketing in the air hose manufacturer to understand and address common questions and concerns related to this.. And malfunctions to the foam in the U.S. had demonstrated acceptable results not established that the filters can the... At https: //www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508 adverse events and to. The elements needed, we may reach out hereto find contact information and (... Need to log in to the foam material used for sound reduction their.

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