The DME supplier can check to see if your device has been recalled. The FDA classified the June 2021 Philips recall of certain ventilators, BIPAP machines, and CPAP machines as a Class I recall, the most serious type of recall. 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 For more information of the potential health risks identified, see the FDA Safety Communication. 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. Membership & Community. If you have any concerns we suggest you contact your durable medical equipment provider or your sleep specialist.Per Philips Respironics, all patients using one of their PAP devices should discontinue use immediately due to the health risks. The FDA has worked with patients and health care professional organizations, including the American Sleep Apnea Association, the COPD (chronic obstructive pulmonary disease) Foundation, the Muscular Dystrophy Association, the Mended Hearts, Inc., American College of Chest Physicians, American Thoracic Society, and the American Academy of Sleep Medicine, and has included this feedback in these FAQs. We recommend you upload your proof of purchase, so you always have it in case you need it. Didn't include your email during registration? To register your product, youll need to. Create account Create an account Already have an account? 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. 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. 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. Please switch auto forms mode to off. We will automatically match your registered device serial number back to our partner inventory registrations. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand Only clean your device according to the manufacturers recommendations. You can also visit philips.com/src-update for information and answers to frequently asked questions. We understand this can be concerning and want to remind you of the following ways you can confirm whether a contact is from Philips Respironics: We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. Philips may contact some patients via phone and ask for their physician's contact information, and then Philips will contact the physician directly so that the prescription can be sent to the contact information below: Tel: 1-857-758-7090 Fax: 1-331-233-0129 Email: RecallPrescriptions@philips.com PAP Recall Guidance If you use a Philips Respironics CPAP or BiPAP device that is included in the recall, continue using your device as prescribed until a new device is available. Please note that if your order is already placed, you may not need to provide this information. 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. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. The FDA developed this page to address questions about these recalls and provide more information and additional resources. 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. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Very small particles from the foam could break lose and come through the air hose. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. The Clinical Centers of Excellence (CCEs) and the Nationwide Provider Network (NPN) are reviewing medical records and working with the Programs medical equipment providers to identify members using the recalled models. 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. We will automatically match your registered device serial number back to our partner inventory registrations. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. Cleaning, setup and return instructions can be found here. 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. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. a. To access the menus on this page please perform the following steps. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. In the US, the recall notification has been classified by the FDA as a Class I recall. 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. Please note that if your order is already placed, you may not need to provide this information. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . 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 recall of certain ventilators, BiPAP machines, and CPAP machines (Recalled Products), as follows: In addition, Philips, as a medical device manufacturer, must comply with all applicable laws and regulations, including quality system regulations (21 CFR Part 820). This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. I need to change my registration information. endstream endobj startxref Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. classified by the FDA as a Class I recall. Call us at +1-877-907-7508 to add your email. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. During the registration process, Philips Respironics will either let you know your machine is not included in the recall or provide you with a confirmation number. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. I have received my replacement device and would like to report a quality issue. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. 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. On March 10, 2022, the FDA issued a notification order under section 518(a) of the Federal Food, Drug, and Cosmetic Act [a 518(a) order] to Philips requiring the company to notify patients and others of the company's June 14, 2021, recall and the unreasonable risk of substantial harm to the public health posed by the degradation of the PE-PUR sound abatement foam used in the recalled products because the company's notification efforts to date have been inadequate. 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. hbbd``b` $@5HqXA5D4O"^ ar?O 1 + Steps to return your affected device: By returning your original device, you can help other patients. 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. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. Philips Respironics has issued a . To support you and the clinical community through the full remediation process we have developed a range of resources to help you support your patients. Looking for U.S. government information and services? Koninklijke Philips N.V., 2004 - 2023. That will allow them place an order for your supplies. Identifying the recalled medical devices and notifying affected customers. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). Understand how were handling the recall and know what to expect, We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. 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. If you use one of these recalled devices, follow the recommendations listed below. Access the menus on this page please perform the following steps, there. Automatically match your registered device serial number back to our partner inventory registrations please perform the steps... May contribute to breakdown of the foam remember to save your confirmation number which will repaired! Page please perform the following steps break lose and come through the device, please remember to save confirmation! Physician on a suitable treatment plan mean the ventilator will not ventilate adequately account create an account already have account. 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