hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. You can log in or create one. 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. 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. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. 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. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. I am experiencing technical issues with the Patient Portal. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Well reach out via phone or email with questions and you can always check your order status online. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. 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. You are about to visit a Philips global content page. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. 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. All rights reserved. The reasons for this recall are due to particles that may be visible in the air pathway of the device and can be ingested or inhaled by the user, Also the off-gas of certain chemicals from the foam. For more information of the potential health risks identified, see the FDA Safety Communication. To access the menus on this page please perform the following steps. Lifestyle Measures to Manage Sleep Apnea fact sheet. We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. Questions regarding registration, updating contact information (including address), or to cancel a registration. Cleaning, setup and return instructions can be found here. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. There were no reports of patient injury or death among those 30 MDRs. Steps to return your affected device: By returning your original device, you can help other patients. 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. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. Can we help? *. No. 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. The .gov means its official.Federal government websites often end in .gov or .mil. We will automatically match your registered device serial number back to our partner inventory registrations. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. * This is a recall notification for the US only, and a field safety notice for the rest of the world. Philips may contact some patients via phone and ask for their physician's contact information, and then Philips will contact the physician directly so that the prescription can be sent to the contact information below: Tel: 1-857-758-7090 Fax: 1-331-233-0129 Email: RecallPrescriptions@philips.com PAP Recall Guidance By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. Find out more about device replacement prioritization and our shipment of replacement devices. Once your order is placed the order number will be listed in the Patient Portal. You are about to visit a Philips global content page. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. You are about to visit the Philips USA website. 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 Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. Well start processing your replacement device order once: 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. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. You can create one here. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. You can still register your device on DreamMapper to view your therapy data. 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 is the leading provider of innovative solutions for the global sleep and respiratory markets. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. 2. On March 10, 2022, the FDA issued a notification order under section 518(a) of the Federal Food, Drug, and Cosmetic Act [a 518(a) order] to Philips requiring the company to notify patients and others of the company's June 14, 2021, recall and the unreasonable risk of substantial harm to the public health posed by the degradation of the PE-PUR sound abatement foam used in the recalled products because the company's notification efforts to date have been inadequate. 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. Do not use ozone or ultraviolet (UV) light cleaners. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. The data collected will be used to help to prioritize remediation of those patients at higher risk. 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 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. 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. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. Access all your product information in one place (orders, subscriptions, etc. Philips has not yet provided the FDA with all information we requested to evaluate the risks from the chemicals released from the foam, though they have posted Clinical information for physicians on their website. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . Since April 2021, the FDA has received more than 98,000 MDRs, including 346 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown. 2. We appreciate your cooperation in this effort, and if you have any questions or if you havent received a package slip or are missing accessories, please contact us at +1-833-262-1871. 2. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Lock 287 0 obj <>/Filter/FlateDecode/ID[<2A6CDD5A2183954AB3A0FBD06BB4042B><32D62A00121D464980178B97B568D612>]/Index[272 32]/Info 271 0 R/Length 78/Prev 140139/Root 273 0 R/Size 304/Type/XRef/W[1 2 1]>>stream 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. The FDA's evaluation of the information provided by Philips is ongoing. This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. Return of your recalled device: If you receive a replacement device, the return information will be sent to you by the method selected during the registration, such as by text, mail, or email. That will allow them place an order for your supplies. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication about the Philips Respironics (Philips) recalled ventilators, bilevel positive airway pressure (also. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. To register your product, youll need to. Veterans Crisis Line: Once you've registered your device, please remember to save your confirmation number which will be emailed to you. 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. Didn't include your email during registration? Repairing and replacing the recalled devices. 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. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. Trying to or successfully removing the foam may damage the device or change how the device works. CDRH will consider the response when it is received. Only clean your device according to the manufacturers recommendations. You may have to contact your care provider to program the device to your prescribed settings. classified by the FDA as a Class I recall. There are no updates to this guidance. Provide a link for health care providers and registrants to access all available testing results and third party confirmed conclusions on results and findings from testing PE-PUR foam used in devices manufactured by Philips for VOCs and particulates, regardless of the Philips device that the foam may have been tested in. Please note that if your order is already placed, you may not need to provide this information. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, Recalled BiPAP or CPAP Machines & Recommendations, Repaired and Replaced BiPAP or CPAP Machines & Recommendations, Potential Health Risks from the PE-PUR Foam, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Register your device(s) on Philips' recall website, report the issue or problem through the MedWatch Voluntary Reporting Form, problem through the MedWatch Voluntary Reporting Form, potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories, report the problem through the MedWatch Voluntary Reporting Form, FDA's user facility reporting requirements, Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Garbin Plus, Aeris, LifeVent (ventilator). Medical guidance regarding this recall. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. The FDA classified the June 2021 Philips recall of certain ventilators, BIPAP machines, and CPAP machines as a Class I recall, the most serious type of recall. Foam: Do not try to remove the foam from your device. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. If you have a health issue and are using or have used a recalled or replaced device or have any problem with your device, talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. I need to change my registration information. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. We have started to ship new devices and have increased our production capacity. Philips Respironics (Philips) voluntarily recalled certain 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. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. 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. You are about to visit a Philips global content page. 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. the .gov website. All rights reserved. Please visit the Patient Portalfor additional information on your status. On June 14, 2021, Royal Philips' subsidiary, Philips Respironics, initiated a voluntary recall notification * for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. 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). Philips Sleep and respiratory care. The PE-PUR foam used in the recalled devices may break down and can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. To register your device and check if your machine is included in the recall: Locate the serial number of your device. Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. Although MDRs are a valuable source of information, this passive surveillance system has limitations. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. The DME supplier can check to see if your device has been recalled. Your replacement device will include three key pieces of information, including how-to: If you need more information, scan the QR codes and call our support team at +1-833-262-1871 with any questions. 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