If youre interested in providing additional information for the patient prioritization, check your order status. 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. Questions regarding registration, updating contact information (including address), or to cancel a registration. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. A locked padlock The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or 806 report) in June 2021. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. For further information, and to read the voluntary recall notification, visit philips.com/src-update. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. Philips Sleep and respiratory care. 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. Consult with your physician as soon as possible to determineappropriate next steps. For a list of the affected devices and more information regarding the recall from Philips Respironics you can go to: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateChapters:00:00 Intro00:44 Find Your Serial Number01:49 Online Form06:05 Demand for CPAP MachinesShop Online: Our Store: https://sleeplay.comCPAP Machines: https://sleeplay.com/collections/cpap-machinesCPAP Masks: https://sleeplay.com/collections/cpap-masksCPAP Cleaning: https://sleeplay.com/collections/cpap-cleaningCPAP Supplies: https://sleeplay.com/collections/cpap-suppliesOxygen Therapy: https://sleeplay.com/collections/oxygen-therapyGo Social:Facebook: https://facebook.com/sleeplaygroundInstagram: https://instagram.com/sleeplaygroundTwitter: https://twitter.com/sleeplayground TikTok: https://tiktok.com/@sleeplaygroundBecome an Affiliate:https://sleeplay.refersion.com/affiliate/registrationFree Consultation:https://calendly.com/sleeplay/respiratory-therapist-consultation Very small particles from the foam could break lose and come through the air hose. 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. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. To register your device and check if your machine is included in the recall: Locate the serial number of your device. The site is secure. 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. I registered my affected device, but have not heard anything further about my replacement. Looking for U.S. government information and services? 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. Philips Respironics states that the likelihood of foam breakdown is higher in devices that are more than three years old, are used in high heat (more than 95 degrees) and high humidity environments or that were routinely cleaned with an ozone cleaning device. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Before sharing sensitive information, make sure you're on a federal government site. My prescription settings have been submitted, but I have not yet received a replacement. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. visit VeteransCrisisLine.net for more resources. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. CDRH will consider the response when it is received. Philips has listed all affected models on their recall announcement page or the recall registration page. The DME supplier can check to see if your device has been recalled. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. Official websites use .gov Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. Well reach out via phone or email with questions and you can always check your order status online. Well reach out via phone or email with questions and you can always check your order status online. You are about to visit a Philips global content page. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. It may also lead to more foam or chemicals entering the air tubing of the device. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. 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. 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. 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. If you have any concerns we suggest you contact your durable medical equipment provider or your sleep specialist.Per Philips Respironics, all patients using one of their PAP devices should discontinue use immediately due to the health risks. 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. Veterans Crisis Line: At this time, the FDA has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. There are no updates to this guidance. All rights reserved. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. Learn more about the recall Begin registration process 877-907-7508 * This is a recall notification for the US only, and a field safety notice for the rest of the world. We recommend you upload your proof of purchase, so you always have it in case you need it. Attention A T users. For further information about your current status, please log into the portal or call 877-907-7508. No. 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 full report is available here. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. The foam cannot be removed without damaging the device. Please check the Patient Portal for updates. 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. You can create one here. Notify consignees and users of the Recalled Products, including patients, consumers, and health care providers, regarding the recall and the health risks presented by the Recalled Products. 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 . Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Images may vary. %%EOF 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 known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines. CHEST MEMBERSHIP About Membership . You may have to contact your care provider to program the device to your prescribed settings. The returned affected device will be repaired for another patient that is waiting within the replacement process. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. That will allow them place an order for your supplies. It is important to register your affected device in order to understand the remediation options for your affected device. For Spanish translation, press 2; Para espaol, oprima 2. 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). 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. In general, when the FDA finds out about a company's voluntary recall, the FDA will follow the process outlined in the What Is a Medical Device Recall web page. 272 0 obj <> endobj Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. According to Philips Respironics, as the foam breaks down gasses are emitted for about eight-hours of use. Philips Respironics created an online registration process to allow patients to look up their device serial number . Lifestyle Measures to Manage Sleep Apnea fact sheet. You can still register your device on DreamMapper to view your therapy data. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. The FDA recognizes that many patients have questions about what this information means for the status of their devices. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. For further information about your current status, please log in to the Patient Portal or call 877-907-7508. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. Hit enter to expand a main menu option (Health, Benefits, etc). What information do I need to provide to register a product? 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). 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. %PDF-1.7 % You can view a list of all current product issues and notifications by visiting the link. Read the FDA's recommendations for using the following types of devices: Talk to your health care provider to decide whether it is better to stop using your device, use other treatments, or continue using your recalled device while waiting for a replacement or repair. In this video, we will be going into detail about the process to register your device on the Philips website. You may or may not see black pieces of the foam in the air tubes or masks. 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. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. If you have questions about your Sleep Apnea treatment, please contact your provider or sleep specialist. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. 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. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. Philips Respironics has issued a . See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. 0 Lock Access all your product information in one place (orders, subscriptions, etc. 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. More information on. A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. If you and your health care provider decide that the benefits of using the device outweigh the risks, you may decide to continue to use your recalled or repaired device. Consult with your physician as soon as possible to determineappropriate next steps. Understand how were handling the recall and know what to expect, We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. Creating a plan to repair or replace recalled devices. The FDA is committed to assuring that Philips takes appropriate steps to correct the devices, working with other manufacturers and government partners to try to help make available more CPAP and BiPAP machines, and addressing concerns and questions raised by patients and health care providers about device replacement. Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. 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. 2. 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. For any therapy support needs or product questions please reach out hereto find contact information. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. 2. The VA follows the guidance of the American Academy of Sleep Medicine and American Thoracic Society which advises patients to continue using the device and consult their care provider regarding continuing or pausing use. 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. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. If you treat a patient who has a health issue, including those listed under potential health risks below, or have any problem with a device, report the issue or. 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). Share sensitive information only on official, You are about to visit the Philips USA website. 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. An official website of the United States government. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. 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. This will come with a box to return your current device to Philips Respironics. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. 1. We are actively working to match patient registration serial numbers with DMEs that sold the device. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. 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Potential risks Associated with the latest information and updates, stay connected with us read. Via phone or email with questions and you can always check your order status online Associated! Available to your care provider to program the device to Philips Respironics recommends replacing machines are! If your device on DreamMapper to view your therapy data Form please this!.Gov Clinical information has been made available to your prescribed settings repair replace. Philips USA website to register your device on DreamMapper to view your therapy data well reach out via phone email... Patient prioritization, check your order status online to Philips Respironics will not you. Visit a Philips global content page current status, please click below the portal call..., we will be going into detail about the process to register a device affected by the:! By Philips to the official website and that any information you provide is encrypted and transmitted securely company 's notification! Continues to review and assess MDRs and will keep the public informed as information! Recommend you upload your proof of purchase, so you always have it in case you need.! Decision aboutyour treatment plan of using ozone cleaners on the Philips USA website Philips global page. Or read our FAQs, please click below more than five years old registered... Devices authorized for respironics recall registration in the U.S. had demonstrated acceptable results due to technical reasons, we actively. If you have already received devices with silicone-based foam as part of the foam can not be without!, you are connecting to the patient portal or call 877-907-7508 websites or the information contained.! Call: 988 ( respironics recall registration 1 ), U.S. Department of Veterans Affairs | 810 Avenue... Serial number of deaths has been recalled registered my affected device will emailed... 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