Can we help? Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. All rights reserved. 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. You can create one here. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers 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. Koninklijke Philips N.V., 2004 - 2023. 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. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. 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. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. You can also upload your proof of purchase should you need it for any future service or repairs needs. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. To register your product, youll need to log in to your My Philips account. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. The foam cannot be removed without damaging the device. We may request contact information, date of birth, device prescription or physician information. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. The relevant heath information that will be asked includes: An occupation associated with public safety. The potential health risks from the foam are described in the FDA's safety communication. To register your device and check if your machine is included in the recall: Locate the serial number of your device. If you have an affected Philips Respironics device, register it one of two ways: You should register your device so that it can either be repaired or replaced. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Philips Respironics Recall Information On June 14, 2021, Philips Respironics announced a voluntary recall of all CPAP, BiPAP, and Ventilator devices manufactured prior to April 21, 2021. You may or may not see black pieces of the foam in the air tubes or masks. Looking for U.S. government information and services? There are no updates to this guidance. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. 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. We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. Positional therapy, such as elevating the head of your bed, using a device that prevents you from turning to your side or back, or avoiding sleeping on your back. See the FDA Safety Communication for more information. Entering your device's serial number during registration will tell you if it is one of the. The PE-PUR foam issue may result from exposure to hot and humid conditions and may be exacerbated by the use of ozone cleaners or other cleaning methods not recommended by the manufacturer. 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. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. We have started to ship new devices and have increased our production capacity. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. A .gov website belongs to an official government benefits outweigh the risks identified in the recall notification. The full report is available 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 If you are in crisis or having thoughts of suicide, More information on. 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 full report is available here. The site is secure. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replace program discontinue use of their product. Share sensitive information only on official, While there is a potential risk from the deterioration of the foam, those risks have to be balanced against the known health risks of untreated sleep apnea. 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 would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. 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. There are currently no items in your shopping cart. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. The information currently available on Philips' website is vague, and does not provide health care providers with the facts necessary for them to make informed decisions regarding the risks associated with the continued use of the Recalled Products for their patients. The data collected will be used to help to prioritize remediation of those patients at higher risk. %%EOF 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. 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. *. Philips was provided an opportunity for an informal hearing before the FDA determines whether to issue an order requiring Philips to submit a plan for the repair, replacement, or refund of the purchase price (less a reasonable allowance for use if the device has been in possession of the user for one year or more). Our Prescription Team is required to review all prescriptions. If you do not find your device on the list, then it has not been recalled and you should continue to use it. 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. 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. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. Trying to or successfully removing the foam may damage the device or change how the device works. 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. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. For further information about your current status, please log in to the. When the PE-PUR foam breaks down, it may: The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include: The potential risks of inhaling chemicals released into the device's air tubes from the PE-PUR foam include: During the 2021 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 VOCs. 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. visit VeteransCrisisLine.net for more resources. I would like to learn more about my replacement device. Well reach out via phone or email with questions and you can always check your order status online. Find out more about device replacement prioritization and our shipment of replacement devices. For further information about your current status, please log in to the Patient Portal or call 877-907-7508. Consult with your physician as soon as possible to determineappropriate next steps. 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. Although MDRs are a valuable source of information, this passive surveillance system has limitations. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Before sharing sensitive information, make sure you're on a federal government site. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. If you have already consulted with your physician, no further action is required of you withregards to this update. 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 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. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. 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. There were no reports of patient injury or death among those 30 MDRs. CDRH will consider the response when it is received. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. If youre interested in providing additional information for the patient prioritization, check your order status. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. You must register your recalled device to get a new replacement device. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. If you have already consulted with your physician, no further action is required of you withregards to this update. To ensure patients with the greatest needs receive a replacement device as timely as possible, we will be prioritizing remediation efforts around certain patients as requested by the US Food & Drug Administration (FDA) and the medical community. 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. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. I have received my replacement device and would like to report a quality issue. You are about to visit a Philips global content page. To register your product, youll need to log in to your My Philips account. Membership. Keep your registration confirmation number. If you and your health care provider decide that the benefits of using the device outweigh the risks, you may decide to continue to use your recalled or repaired device. Philips Respironics issued a statement on September 1, 2021 informing United States-based customers of its new repair and replacement program for first-generation DreamStation devices in relation to the June 14, 2021 recall notification.The vast majority of the registered affected devicesmore than 80%are from the first-generation DreamStation product family, and more than half of the . The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. My issue is not addressed here. The .gov means its official.Federal government websites often end in .gov or .mil. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. 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. Before sharing sensitive information, make sure you're on a federal government site. 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. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Philips Respironics continues to monitor recall awareness for affected patients [1]. 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. 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. For further information about your current status, please log into the portal or call 877-907-7508. A voluntary recall has been announced by Philips Respironics for the following: A voluntary recall is when a manufacturer removes a product from use due to a potential product safety issue. Call us at +1-877-907-7508 to add your email. All rights reserved. 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. A locked padlock Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. 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