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. Create account Create an account Already have an account? The full report is available here. 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 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. While we havealready made progress in shipping replacement devices, and have increased our production capacity, weanticipate the repair and replacement program in the US will take through approximately September 2022to complete. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. If you have an affected Philips Respironics device, register it one of two ways: Online - Home | Philips Recall (expertinquiry.com) Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to . Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Be cautious as they may be scams! 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). 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. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. hbbd``b` $@5HqXA5D4O"^ ar?O 1 + Register your device (s) on Philips Respironics' recall website to stay informed of updates from Philips Respironics regarding any new instructions or other corrective fixes, which the FDA. hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX h?>~LJ3AF E : Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers 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. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. 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. Philips Respironics (Philips) voluntarily recalledcertain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. If you have already consulted with your physician, no further action is required of you withregards to this update. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. 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. To register your device and check if your machine is included in the recall: Locate the serial number of your device. Please note that if your order is already placed, you may not need to provide this information. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. If we have attempted to reach you through multiple avenues the request may appear very generic in nature and will contain a Philips Respironics customer service number. 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. 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. The .gov means its official.Federal government websites often end in .gov or .mil. You can still register your device on DreamMapper to view your therapy data. Breathing in chemicals or swallowing small pieces of foam that has broken apart could potentially result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury. To access the menus on this page please perform the following steps. 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. 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 data collected will be used to help to prioritize remediation of those patients at higher risk. 1. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. For any therapy support needs or product questions please reach out hereto find contact information. 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. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. Please switch auto forms mode to off. There are no updates to this guidance. Membership. 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. Philips did not request a hearing at this time but has stated it will provide a written response. 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. Apologize for any inconvenience. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. You are about to visit the Philips USA website. You can also visit philips.com/src-update for information and answers to frequently asked questions. You must register your recalled device to get a new replacement device. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices Sign in now New to My Philips? 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. Please call our registration line or visit our registration website. 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. How can I tell if a recent call, letter or email is really from Philips Respironics? More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Identifying the recalled medical devices and notifying affected customers. A locked padlock The data collected will be used to help to prioritize remediation of those patients at higher risk. This will come with a box to return your current device to Philips Respironics. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. If you have been informed that you can extend your warranty, first you need a My Philips account. Call us at +1-877-907-7508 to add your email. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. You are about to visit the Philips USA website. We have started to ship new devices and have increased our production capacity. Use another similar device that is not a part of this recall. a. The FDA's evaluation of the information provided by Philips is ongoing. 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 potential health risks from the foam are described in the FDA's safety communication. Log in Trying to or successfully removing the foam may damage the device or change how the device works. My issue is not addressed here. Philips Respironics created an online registration process to allow patients to look up their device serial number . The full report is available here. Philips Respironics Sleep and Respiratory Care devices Register your device In June 2021, after discovering a potential health risk related to a part in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). You can log in or create one here. We may request contact information, date of birth, device prescription or physician information. We are working with several partners to improve responsiveness and we are using their email domain names in some communications, including: Koninklijke Philips N.V., 2004 - 2023. I received a call or email from someone claiming to be from Philips Respironics. More information is available at http://www.philips.com/src-update. The relevant heath information that will be asked includes: 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. 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. Keep your registration confirmation number. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. If we have attempted to reach you through multiple avenues the request may appear very generic in nature and will contain a Philips Respironics customer service number. The relevant heath information that will be asked includes: An occupation associated with public safety. You can log in or create one. 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. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. 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 On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. Before sharing sensitive information, make sure you're on a federal government site. 0 Your replacement device will include three key pieces of information, including how-to: Set up your device Clean and assemble existing components Return instructions. Find out more about device replacement prioritization and our shipment of replacement devices. 272 0 obj <> endobj That will allow them place an order for your supplies. Membership & Community. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. Access all your product information in one place (orders, subscriptions, etc. Eight of those reports were from the U.S. All rights reserved. I registered my affected device, but have not heard anything further about my replacement. The more we know about these devices the more research we can do.". Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. 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. For further information about your current status, please log in to the Patient Portal or call 877-907-7508. They are undetectable after 24 hours of use. 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. 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. The site is secure. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. Call us at +1-877-907-7508 to add your email. Cpap machines 1 ), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington 20420... Of you withregards to this update to get a new replacement device may be required take... 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