If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. 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. More information on. The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. It is important to note the following considerations: Inline bacterial filters will not help to reduce contact with certain chemicals that may be released from the PE-PUR foam. 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 will keep the public informed as more information becomes available. Other potential risks identified by Philips Respironics from degraded foam exposure include: Skin, eye and respiratory irritation, headache, asthma, adverse effects to other organs (e.g. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. 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. Didn't include your email during registration? Membership & Community. Not yet registered? 0 By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Call us at +1-877-907-7508 to add your email. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. 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. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. There are no updates to this guidance. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to register your CPAP machine / BIPAP machine/mechanical ventilator devices for the Philips Respironics Recall. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. Veterans Crisis Line: 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. To register a new purchase, please have the product on hand and log into your My Philips account. VA clinical experts are working with the FDA and the manufacturer to understand those risks. Trying to or successfully removing the foam may damage the device or change how the device works. Call us at +1-877-907-7508 to add your email. I need to change my registration information. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. Home | Philips Recall (expertinquiry.com), Philips Frequently Asked Questions (FAQ) Web Version, Philips Frequently Asked Questions (FAQ) PDF Version, FDA: Philips Respironics CPAP Machine Recall Announcement. You will need to keep and clean these to use with your replacement device, Using packing tape supplied, close your box, and seal it, Affix the pre-paid postage label to the box and schedule a pick up at your local FedEx. A .gov website belongs to an official government Our Prescription Team is required to review all prescriptions. 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. To enter and activate the submenu links, hit the down arrow. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. It may also lead to more foam or chemicals entering the air tubing of the device. 2. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. 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. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. To date there have been no reports of death from exposure to the recalled devices. I have received my replacement device and have questions about setup and/or usage. On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. 1. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. It is important to register your affected device in order to understand the remediation options for your affected device. News and Updates> Important update to Philips US recall notification. CHEST MEMBERSHIP About Membership . 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. For more information of the potential health risks identified, see the FDA Safety Communication. You are about to visit a Philips global content page. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. Please watch the video below from fellow Veteran and CPAP user, Dr. Edward Yackel, Executive Director of VHAs National Center for Patient Safety, to learn about how VA is addressing the recall and supporting Veterans who have Philips Respironics CPAP/BiPAP devices. the .gov website. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). 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. secure websites. The full report is available here. For your immediate reference, the July 9, 2021 joint position statement by The Canadian Thoracic Society, Canadian Sleep Society and the Canadian Society of Respiratory Therapists states: . Do not use ozone or ultraviolet (UV) light cleaners. For further information about your current status, please log into the portal or call 877-907-7508. There are currently no items in your shopping cart. Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. Office of Accountability & Whistleblower Protection, Training - Exposure - Experience (TEE) Tournament, Chief Resident in Quality and Patient Safety, About the National Center for Patient Safety, War Related Illness & Injury Study Center, Clinical Trainees (Academic Affiliations), https://www.philipssrcupdate.expertinquiry.com, Call TTY if you The FDA developed this page to address questions about these recalls and provide more information and additional resources. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. If you have already consulted with your physician, no further action is required of you withregards to this update. You are about to visit a Philips global content page. Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices 3,950,000 repair kits and replacement devices produced to date globally 2,000,000 devices shipped in the US 22 Questions 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. Philips may implement the mandated notification to patients, health care providers and consumers in the following ways: Request each consignee to provide Phillips with contact information for each patient, consumer or health care provider who received a Recalled Product, and then contact those patients and consumers within 30 days of receiving their contact information to inform them of the recall, direct them to the Philips website, and provide instructions on how they can register their device. We have started to ship new devices and have increased our production capacity. %%EOF If you use one of these recalled devices, follow the recommendations listed below. We recommend you upload your proof of purchase, so you always have it in case you need it. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. Determining the number of devices in use and in distribution. The data collected will be used to help to prioritize remediation of those patients at higher risk. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. 2. 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. 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