Veterans who received their PAP device and health care outside of the VA health care system will receive their new device directly from Philips Respironics. 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. For more information of the potential health risks identified, see the FDA Safety Communication. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. All rights reserved. You are about to visit the Philips USA website. 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 have an affected Philips Respironics device, register it one of two ways: Online - Home | Philips Recall (expertinquiry.com) Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to . An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, Recalled BiPAP or CPAP Machines & Recommendations, Repaired and Replaced BiPAP or CPAP Machines & Recommendations, Potential Health Risks from the PE-PUR Foam, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Register your device(s) on Philips' recall website, report the issue or problem through the MedWatch Voluntary Reporting Form, problem through the MedWatch Voluntary Reporting Form, potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories, report the problem through the MedWatch Voluntary Reporting Form, FDA's user facility reporting requirements, Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Garbin Plus, Aeris, LifeVent (ventilator). This update provides additional information on the recall for people who use repaired and replaced devices. Share sensitive information only on official, The recall notification (U.S. only) / field safety notice (Outside of U.S.) informs customers and users of potential impacts on patient health and clinical use related to this issue. Please switch auto forms mode to off. Very small particles from the foam could break lose and come through the air hose. The more we know about these devices the more research we can do.". Since your physician knows your medical history, they are the most qualified person todetermine the benefit or risk of staying on your therapy until you receive your replacement device. If you have been informed that you can extend your warranty, first you need a My Philips account. Do not stop or change ventilator use until you have talked to your health care provider. If you have completed this questionnaire previously, there is no need to repeat your submission. Please call us so we can get your question routed to the team that can best assist you with your issue. . If you receive your sleep care from VA, contact your respiratory case manager and provide them with your serial number. A locked padlock Register your product and start enjoying benefits right away. Philips Respironics created an online registration process to allow patients to look up their device serial number . To register your product, youll need to log in to your My Philips account. 1. Register your device (s) on Philips Respironics' recall website to stay informed of updates from Philips Respironics regarding any new instructions or other corrective fixes, which the FDA. The data collected will be used to help to prioritize remediation of those patients at higher risk. Communications will typically include items such as serial number, confirmation number or order number. We will keep the public informed as more information becomes available. Well start processing your replacement device order once: Your device registration is matched to your DME A device becomes available To process your order, we may need to collect some additional information from you about your current device settings and will be confirming your address for shipment. The FDA recommended, and Philips has agreed, to implement a prioritization approach that ensures patients who are most vulnerable to poor health care outcomes with continued use or ceasing use of the Recalled Products receive replacement devices as quickly as possible. 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? For further information about your current status, please log into the portal or call 877-907-7508. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. No. There were no reports of patient injury or death among those 30 MDRs. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. UPDATE - December 22, 2022: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. My issue is not addressed here. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. 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. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Call us at +1-877-907-7508 to add your email. 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. On June 14, 2021, Royal Philips' subsidiary, Philips Respironics, initiated a voluntary recall notification * for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. Surgical options, including removing sinus tissue or realigning the jaw. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. Three types of devices have been recalled: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Trilogy 100 and Trilogy 200 ventilators. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. Lock You are about to visit a Philips global content page. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. 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. 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. In the US, the recall notification has been. visit VeteransCrisisLine.net for more resources. If we have attempted to reach you through multiple avenues the request may appear very generic in nature and will contain a Philips Respironics customer service number. The DME supplier can check to see if your device has been recalled. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. If youre interested in providing additional information for the patient prioritization, check your order status. Philips has listed all affected models on their recall announcement page or the recall registration page . 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, and the FDA will communicate those results to the public as soon as they are available. Koninklijke Philips N.V., 2004 - 2023. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. classified by the FDA as a Class I recall. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. While we work to provide patients with a replacement device as quickly as possible, we want you to feel informed about each step of the remediation process, and confident in your new device. A lock ( The .gov means its official.Federal government websites often end in .gov or .mil. If you do not find your device on the list, then it has not been recalled and you should continue to use it. You can also upload your proof of purchase should you need it for any future service or repairs needs. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. 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