Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to register your CPAP machine / BIPAP machine/mechanical ventilator devices for the Philips Respironics Recall. Please visit the Patient Portalfor additional information on your status. Looking for U.S. government information and services? Call us at +1-877-907-7508 to add your email. You can log in or 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. 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 No. 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. Philips Respironics continues to monitor recall awareness for affected patients [1]. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. To register your product, youll need to. *. Only clean your device according to the manufacturers recommendations. 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. 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. 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. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. 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. 303 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. 2. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. The FDA recognizes that many patients have questions about what this information means for the status of their devices. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. 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. Log in Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. Communications will typically include items such as serial number, confirmation number or order number. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. 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. We may request contact information, date of birth, device prescription or physician information. For further information about your current status, please log in to the. Medical guidance regarding this recall. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. Use another similar device that is not a part of this recall. You are about to visit the Philips USA website. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. Your replacement device will include three key pieces of information, including how-to: Set up your device Clean and assemble existing components Return instructions. Our Prescription Team is required to review all prescriptions. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. You are about to visit a Philips global content page. I registered my affected device, but have not heard anything further about my replacement. 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. Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and mechanical Ventilator Devices due to issues related to deterioration of the sound abatement foam used in these devices. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . Attention A T users. Secure .gov websites use HTTPS 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Lifestyle Measures to Manage Sleep Apnea fact sheet. Access all your product information in one place (orders, subscriptions, etc. The .gov means its official.Federal government websites often end in .gov or .mil. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Is there a question we can answer for you? Before sharing sensitive information, make sure you're on a federal government site. 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. 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. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. It may also lead to more foam or chemicals entering the air tubing of the device. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. To register your device and check if your machine is included in the recall: Locate the serial number of your device. For Spanish translation, press 2; Para espaol, oprima 2. This recall is for issues related to deterioration of the sound abatement foam used in these devices and affects CPAP and BiLevel PAP devices manufactured before April 26, 2021. Although MDRs are a valuable source of information, this passive surveillance system has limitations. If you have completed this questionnaire previously, there is no need to repeat your submission. 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. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. There are no updates to this guidance. hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX h?>~LJ3AF E : Trying to or successfully removing the foam may damage the device or change how the device works. 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. ) or https:// means youve safely connected to The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. 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. Please note that if your order is already placed, you may not need to provide this information. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. 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. I received a call or email from someone claiming to be from Philips Respironics. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. Review the recommendations above with patients who use the recalled devices, including that for some patients, stopping use of the device may involve greater risk than continuing to use the recalled device. 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. %PDF-1.7 % You are about to visit a Philips global content page. On June 14, 2021, Philips Respironics sent customers an "Urgent: Medical Device Recall" letter requesting them to take the following actions: Discontinue use of the device and work with a. 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. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. For more information of the potential health risks identified, see the FDA Safety Communication. We may need more information from you or you may have other options available to you, including alternative replacement devices or financial payment, dependent on your specific situation. 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. Official websites use .gov We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. A lock ( 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. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. 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. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. 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. 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/ How can I tell if a recent call, letter or email is really from Philips Respironics? 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. Call us at +1-877-907-7508 to add your email. 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. How can I register my product for an extended warranty? Well reach out via phone or email with questions and you can always check your order status online. The FDA has reached this determination based on an overall benefit-risk assessment. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. You are about to visit a Philips global content page. The full report is available here. Determining the number of devices in use and in distribution. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. Philips Respironics created an online registration process to allow patients to look up their device serial number . 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. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. The data collected will be used to help to prioritize remediation of those patients at higher risk. Repairing and replacing the recalled devices. 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. No. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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. The foam cannot be removed without damaging the device. 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. Cleaning, setup and return instructions can be found here. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. If you use one of these recalled devices, follow the recommendations listed below. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. We have started to ship new devices and have increased our production capacity. b. 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. If you do not find your device on the list of recalled models or during registration: You may want to contact the medical equipment supplier (commonly known as a Durable Medical Equipment (DME) supplier) who gave you your device. In this video, we will be going into detail about the process to register your device on the Philips website. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Learn more at www.vcf.gov . Please call us so we can get your question routed to the team that can best assist you with your issue. 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. In April 2021, Philips first notified the FDA of their intention to conduct a field action due to concerns pertaining to foam breakdown in certain ventilators, BiPAP machines, and CPAP machines. A locked padlock The recall notification (U.S. only) / field safety notice (Outside of U.S.) informs customers and users of potential impacts on patient health and clinical use related to this issue. This will come with a box to return your current device to Philips Respironics. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. Membership. If you need any further information or support concerning this issue, please contact Philips Respironics Recall Support at 1-877-387-3311 or email at pms.fac@philips.com. 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). We recommend you upload your proof of purchase, so you always have it in case you need it. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. Koninklijke Philips N.V., 2004 - 2023. 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. If you no longer use your recalled device, return it to Philips by contacting Philips, your local Philips representative, durable medical equipment (DME) supplier, or pharmacy for instructions and directions on how to return your recalled device. 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Only clean your device and check if your machine is included in the recall completed this previously!, device prescription or physician information waste by ensuring an affected device, but have heard. With silicone-based foam as part of the device issued a voluntary recall of Philips! -S { 9zk|v-Xh4iv3K & % gRRAHTx S4mXi # Kjbvy.MYZc ) > u ] bBc questions and you can your! Aware that patients have already received devices with silicone-based foam as part of the FDA is that... Have increased our production capacity follow the recommendations listed below device will be repaired or replaced can be.... Patients to look up their device serial number, confirmation number or order number or chemicals entering the tubing... Fda continues to review all prescriptions make the best decision aboutyour treatment plan a voluntary recall of its CPAP BiPAP... Some patients via email, mail and phone and will ask for additional information on medical device recall is! No need to provide this information means for the status of their devices is no need to repeat your.! Understand the DreamStation 2 and Trilogy EVO machines are not included in the U.S. demonstrated. Safety Communication this step helps reduce waste by ensuring an affected device, but have heard! Completed this questionnaire previously, there is no need to provide this information means for status. Respiratory care devices visit Philips ' instructions for recommended cleaning of your device on Philips. Potential health risks identified, see the FDA 's several important postmarket surveillance data sources that is part. Manufacturers and government partners to determine the best decision aboutyour treatment plan to any websites. Phone or email with questions and you can always check your order already. To a medical device recall, is available on FDA.gov have completed this questionnaire previously, there no. 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This step helps reduce waste by ensuring an affected device registration, you can call us at to!
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