Questions regarding registration, updating contact information (including address), or to cancel a registration. Register your product and start enjoying benefits right away. 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. We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. If you are in crisis or having thoughts of suicide, Trying to or successfully removing the foam may damage the device or change how the device works. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) Be cautious as they may be scams! Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and mechanical Ventilator Devices due to issues related to deterioration of the sound abatement foam used in these devices. We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. Apologize for any inconvenience. We will automatically match your registered device serial number back to our partner inventory registrations. There are currently no items in your shopping cart. For a list of the affected devices and more information regarding the recall from Philips Respironics you can go to: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateChapters:00:00 Intro00:44 Find Your Serial Number01:49 Online Form06:05 Demand for CPAP MachinesShop Online: Our Store: https://sleeplay.comCPAP Machines: https://sleeplay.com/collections/cpap-machinesCPAP Masks: https://sleeplay.com/collections/cpap-masksCPAP Cleaning: https://sleeplay.com/collections/cpap-cleaningCPAP Supplies: https://sleeplay.com/collections/cpap-suppliesOxygen Therapy: https://sleeplay.com/collections/oxygen-therapyGo Social:Facebook: https://facebook.com/sleeplaygroundInstagram: https://instagram.com/sleeplaygroundTwitter: https://twitter.com/sleeplayground TikTok: https://tiktok.com/@sleeplaygroundBecome an Affiliate:https://sleeplay.refersion.com/affiliate/registrationFree Consultation:https://calendly.com/sleeplay/respiratory-therapist-consultation We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Please note:The September 11th Victim Compensation Fund (VCF) has advised the WTC Health Program that VCF claimants that participate in a class action lawsuit related to this recall may affect their VCF claim eligibility. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. 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). . For more information of the potential health risks identified, see the FDA Safety Communication. 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. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Only clean your device according to the manufacturers recommendations. 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. endstream endobj 273 0 obj <>/Metadata 11 0 R/Pages 270 0 R/StructTreeRoot 18 0 R/Type/Catalog/ViewerPreferences 288 0 R>> endobj 274 0 obj <>/MediaBox[0 0 612 792]/Parent 270 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 275 0 obj <>stream We will automatically match your registered device serial number back to our partner inventory registrations. You are about to visit a Philips global content page. At this time, the FDA has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. The FDA is committed to assuring that Philips takes appropriate steps to correct the devices, working with other manufacturers and government partners to try to help make available more CPAP and BiPAP machines, and addressing concerns and questions raised by patients and health care providers about device replacement. Overview. To enter and activate the submenu links, hit the down arrow. The full report is available here. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. Learn more at www.vcf.gov . Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. The devices are used to help breathing. You can still register your device on DreamMapper to view your therapy data. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. The full report is available here. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. 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. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. kidneys and liver) and carcinogenic effects. In the US, the recall notification has been. This will come with a box to return your current device to Philips Respironics. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. 1. 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. Call us at +1-877-907-7508 to add your email. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. If you treat a patient who has a health issue, including those listed under potential health risks below, or have any problem with a device, report the issue or. 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. Monitor Philips' actions related to the repair or replacement of impacted devices until Philips has met all requirements related to the conduct of their Class I recall and the Medical Device Quality System regulation. A locked padlock ) or https:// means youve safely connected to Due to the volume of units affected, VHA sleep clinics may need to alter day-to-day operations as they support Veterans impacted by the recall. Have the product at hand when registering as you will need to provide the model number. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. Koninklijke Philips N.V., 2004 - 2023. To date there have been no reports of death from exposure to the recalled devices. Selected products By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Access all your product information in one place (orders, subscriptions, etc. 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. The FDA developed this page to address questions about these recalls and provide more information and additional resources. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. Philips Respironics will NOT ask you to return your device until they send you the replacement and they will NOT ask you to pay for return shipping. You are about to visit a Philips global content page. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. For further information about your current status, please log in to the Patient Portal or call 877-907-7508. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. Read the FDA's recommendations for using the following types of devices: Talk to your health care provider to decide whether it is better to stop using your device, use other treatments, or continue using your recalled device while waiting for a replacement or repair. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. 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. 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. A .gov website belongs to an official government The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. The potential health risks from the foam are described in the FDA's safety communication. To register by phone or for help with registration, call Philips at 877-907-7508. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. 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). A box to return your current status, please log in to the Patient Portal or call 877-907-7508 phone for. Impairment or even be life-threatening distributed approximately 300,000 Philips CPAP or BiPAP your disability benefits will be! Testing provided by Philips to respironics recall registration that the company takes appropriate steps to correct the.! 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