*. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") 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. News and Updates> Important update to Philips US recall notification. 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. Repairing and replacing the recalled devices. 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 ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. 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: . 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 . Consult with your physician as soon as possible to determineappropriate next steps. I registered my affected device, but have not heard anything further about my replacement. You can still register your device on DreamMapper to view your therapy data. 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. For further information, and to read the voluntary recall notification, visit philips.com/src-update. 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. Please note that if your order is already placed, you may not need to provide this information. Philips Respironics Sleep and Respiratory Care devices, If you haven't yet registered your device, Important update to Philips US recall notification, Philips has updated the US recall notification to align with the, * This is a recall notification for the US only, and a field safety notice for the rest of the world. The .gov means its official.Federal government websites often end in .gov or .mil. If you use one of these recalled devices, follow the recommendations listed below. You are about to visit the Philips USA website. 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. We may request contact information, date of birth, device prescription or physician information. Membership & Community. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. Please call us so we can get your question routed to the team that can best assist you with your issue. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or 806 report) in June 2021. The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. Official websites use .gov Have the product at hand when registering as you will need to provide the model number. Although MDRs are a valuable source of information, this passive surveillance system has limitations. 1. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. If you have a health issue, including any of the health issues listed above, or any problem with your device, the FDA encourages you to talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. Call us at +1-877-907-7508 to add your email. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. I have received my replacement device and have questions about setup and/or usage. Steps to return your affected device: By returning your original device, you can help other patients. Hit enter to expand a main menu option (Health, Benefits, etc). In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. Since your physician knows your medical history, they are the most qualified person todetermine the benefit or risk of staying on your therapy until you receive your replacement device. Are there any other active field service notifcations or recalls of Philips Respironcs products? 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). Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. You are about to visit a Philips global content page. 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. 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. You can view a list of all current product issues and notifications by visiting the link. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand Devices need to be registered with Philips Respironics to receive a replacement device. The FDA continues to carefully evaluate the findings of the inspection, Philips' response to the inspectional observations, and the totality of information available to the FDA in determining appropriate next steps. 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. For further information about your current status, please log into the portal or call 877-907-7508. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. Foam: Do not try to remove the foam from your device. Our physicians have had many meetings with the manufacturer as well as with other sleep medicine practices, and we currently recommend the following: Call Philips Respironics at 1-877-907-7508 to register your device or register your device via the web at: https://www.philipssrcupdate.expertinquiry.com/ 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. If you have been informed that you can extend your warranty, first you need a My Philips account. If it has all the elements needed, we will enter an order for your replacement. 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. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. You must register your recalled device to get a new replacement device. Call us at +1-877-907-7508 to add your email. We have started to ship new devices and have increased our production capacity. At this time, the FDA does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S. Continue to use your repaired or replaced device. 1. 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. Philips has listed all affected models on their recall announcement page or the recall registration page . Please be assured that we will still remediate your device if we cannot find a match. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. 1. 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. The devices are used to help breathing. 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. 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. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. No. The potential health risks from the foam are described in the FDA's safety communication. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Creating a plan to repair or replace recalled devices. Lifestyle Measures to Manage Sleep Apnea fact sheet. 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. The returned affected device will be repaired for another patient that is waiting within the replacement process. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. All rights reserved. What information do I need to provide to register a product? 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. 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. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. Please note: only certain devices made by Philips are subject to this recall. The FDA recognizes that many patients have questions about what this information means for the status of their devices. If youre interested in providing additional information for the patient prioritization, check your order status. The FDA has reached this determination based on an overall benefit-risk assessment. 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. Philips has pre-paid all shipping charges. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. Our Prescription Team is required to review all prescriptions. We will keep the public informed as more information becomes available. The .gov means its official.Federal government websites often end in .gov or .mil. You can log in or create one here. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. You can create one here. Dont have one? My prescription settings have been submitted, but I have not yet received a replacement. 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). You can log in or create one. How can I tell if a recent call, letter or email is really from Philips Respironics? 2. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. The website provides you current information on the status of the recall and how to receive permanent corrective action to address the two (2) issues. In this video, we will be going into detail about the process to register your device on the Philips website. Didn't include your email during registration? 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. They are undetectable after 24 hours of use. 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. 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. 303 0 obj <>stream 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. 3. 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). Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. 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. The foam was determined to be PE-PUR foam, the same type of foam used in Philips' devices previously recalled in June 2021. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. Eight of those reports were from the U.S. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. 2. Philips Sleep and respiratory care. Following two rounds of comprehensive customer and patient outreach, Philips Respironics has reached the vast majority of the installed base in the US resulting in the registration of approximately 2.6 million devices in the country. Philips Respironics issued a statement on September 1, 2021 informing United States-based customers of its new repair and replacement program for first-generation DreamStation devices in relation to the June 14, 2021 recall notification.The vast majority of the registered affected devicesmore than 80%are from the first-generation DreamStation product family, and more than half of the . The more we know about these devices the more research we can do.". For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. 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. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . More information on. kidneys and liver) and carcinogenic effects. All rights reserved. There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. 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 more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. For patients using life-sustaining ventilation, continue prescribed therapy. This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. Is there a question we can answer for you? Attention A T users. 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. Bipap and CPAP devices, consult with your physician on a suitable treatment.. 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