Manufacturers, such as Philips, are required to submit medical device reports (MDRs) when they become aware of an event that reasonably suggests that one of their devices may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. 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. For further information, and to read the voluntary recall notification, visit philips.com/src-update. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. 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. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. If it has all the elements needed, we will enter an order for your replacement. secure websites. They are undetectable after 24 hours of use. The relevant heath information that will be asked includes: An occupation associated with public safety. organization in the United States. 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. Veterans Crisis Line:
These Philips Trilogy 100 and Trilogy 2000 ventilators were a part of this recall in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. The data collected will be used to help to prioritize remediation of those patients at higher risk. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . 22 Questions . have hearing loss. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. On May 2, 2022, the FDA's Center for Devices and Radiological Health (CDRH) sent notice to Philips that CDRH is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act [a 518(b) order], to require Philips to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after November 2015. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. Repairing and replacing the recalled devices. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. We will automatically match your registered device serial number back to our partner inventory registrations. Contact and support for Philips Respironics voluntary recall Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. 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. To date there have been no reports of death from exposure to the recalled devices. 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. For further information about your current status, please log into the portal or call 877-907-7508. By returning your original device, you can help other patients. 2. 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). Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. 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. 1. Questions regarding registration, updating contact information (including address), or to cancel a registration. visit VeteransCrisisLine.net for more resources. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. We will keep the public informed as more information becomes available. For further information about your current status, please log in to the. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. Learn more at www.vcf.gov . 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. 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. Dont have one? The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Please note, dependent on which customer care team you need to speak with, we may be experiencing a high volume of calls and wait times may be longer than normal. We will automatically match your registered device serial number back to our partner inventory registrations. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. 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. Is there a question we can answer for you? Continuous Positive Airway Pressure (CPAP) devices, Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and, Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to register their device). In the US, the recall notification has been classified by the FDA as a Class I recall. classified by the FDA as a Class I recall. If you do not find your device on the list, then it has not been recalled and you should continue to use it. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. If you have a health issue, including those listed under potential health risks below, or any problem with your device, talk to your health care provider and. Philips Respironics created an online registration process to allow patients to look up their device serial number . These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. You can also visit philips.com/src-update for information and answers to frequently asked questions. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Please note: only certain devices made by Philips are subject to this recall. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. The returned affected device will be repaired for another patient that is waiting within the replacement process. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. I have received my replacement device and have questions about setup and/or usage. 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).
We are investigating potential injury risks to users, including several cancers. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. Apologize for any inconvenience. 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. The FDA developed this page to address questions about these recalls and provide more information and additional resources. Access all your product information in one place (orders, subscriptions, etc. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Although MDRs are a valuable source of information, this passive surveillance system has limitations. 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. In this video, we will be going into detail about the process to register your device on the Philips website. %PDF-1.7
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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. This will allow all end users to make informed decisions regarding the risks of continued use of the Recalled Products while awaiting a replacement device. There are no updates to this guidance. For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Determining the number of devices in use and in distribution. In the alternative, obtain from each consignee documentation confirming that the consignee has provided, within 30 days of receiving Philips' notification, each patient, consumer or health care provider who received a Recalled Product with the Philips notification that informs them of the recall, directs them to Philips' website, and provides instruction on how they can register their device. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. Our Prescription Team is required to review all prescriptions. All rights reserved. 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. 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