Matching your registration to your Durable Medical Equipment provider (DME) Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Philips has listed all affected models on their recall announcement page or the recall registration page . Koninklijke Philips N.V., 2004 - 2023. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. For patients using life-sustaining ventilation, continue prescribed therapy. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. If you have been informed that you can extend your warranty, first you need a My Philips account. See the FDA Safety Communication for more information. Membership & Community. 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. Very small particles from the foam could break lose and come through the air hose. Do not use ozone or ultraviolet (UV) light cleaners. CDRH will consider the response when it is received. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. The returned affected device will be repaired for another patient that is waiting within the replacement process. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. 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. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. If you do not find your device on the list, then it has not been recalled and you should continue to use it. Membership. 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. 2. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. The FDA recognizes that many patients have questions about what this information means for the status of their devices. To register your product, youll need to log in to your My Philips account. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. The site is secure. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. Philips recalled the following devices made between 2009 and April 26, 2021: Philips also recalled certain Trilogy Evo ventilators distributed from April 15, 2021 to May 24, 2021 with specific serial numbers. 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. ) or https:// means youve safely connected to
The full report is available here. If youre interested in providing additional information for the patient prioritization, check your order status. 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). 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. Create account Create an account Already have an account? A .gov website belongs to an official government
You can still register your device on DreamMapper to view your therapy data. We may request contact information, date of birth, device prescription or physician information. I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. You are about to visit a Philips global content page. 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. Do not stop or change ventilator use until you have talked to your health care provider. 22 Questions My prescription settings have been submitted, but I have not yet received a replacement. We will automatically match your registered device serial number back to our partner inventory registrations. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. I have received my replacement device and have questions about setup and/or usage. 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. Didn't include your email during registration? Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. %%EOF
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. Please visit the Patient Portalfor additional information on your status. You can also visit philips.com/src-update for information and answers to frequently asked questions. 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. 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). Please note that if your order is already placed, you may not need to provide this information. I am experiencing technical issues with the Patient Portal. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Please call our registration line or visit our registration website. The foam cannot be removed without damaging the device. VA clinical experts are working with the FDA and the manufacturer to understand those risks. 272 0 obj
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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. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. Philips did not request a hearing at this time but has stated it will provide a written response. Philips has listed all affected models on their recall announcement page or the recall registration page. Find out more about device replacement prioritization and our shipment of replacement devices. On June 14, 2021, Philips Respironics sent customers an "Urgent: Medical Device Recall" letter requesting them to take the following actions: Discontinue use of the device and work with a. Philips Respironics Sleep and Respiratory Care devices, 2. You are about to visit the Philips USA website. 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. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. All rights reserved. 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. Irritation to the skin, eyes, nose, and respiratory tract (airway), Toxic or cancer-causing effects to organs, such as kidneys and liver, Irritation in the eyes, nose, respiratory tract (airway), and skin, Hypersensitivity reaction, such as an allergic reaction or another immune system reaction. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Overview. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. Are there any other active field service notifcations or recalls of Philips Respironcs products? Eight of those reports were from the U.S. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. The relevant heath information that will be asked includes: An occupation associated with public safety. 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. 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. 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