Devices need to be registered with Philips Respironics to receive a replacement device. Philips Sleep and respiratory care. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. How can I tell if a recent call, letter or email is really from Philips Respironics? On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. My issue is not addressed here. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) The FDA recognizes that many patients have questions about what this information means for the status of their devices. What information do I need to provide to register a product? 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. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. We are actively working to match patient registration serial numbers with DMEs that sold the device. Monitor Philips' actions related to the repair or replacement of impacted devices until Philips has met all requirements related to the conduct of their Class I recall and the Medical Device Quality System regulation. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. Our Prescription Team is required to review all prescriptions. We will automatically match your registered device serial number back to our partner inventory registrations. Koninklijke Philips N.V., 2004 - 2023. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. 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). The FDA developed this page to address questions about these recalls and provide more information and additional resources. If you are in crisis or having thoughts of suicide,
Philips has listed all affected models on their recall announcement page or the recall registration page . 2. 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.
Veterans Crisis Line:
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. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. 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: . Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. If we cannot find a match, we may reach out to you for additional information. To register a new purchase, please have the product on hand and log into your My Philips account. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. 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. VA clinical experts are working with the FDA and the manufacturer to understand those risks. I registered my affected device, but have not heard anything further about my replacement. 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). We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. The devices included are CPAP machines due to issues related to the polyester-based polyurethane sound abatement foam used in its continuous and non-continuous ventilators. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. You can create one here. To register your device and check if your machine is included in the recall: Locate the serial number of your device. Apologize for any inconvenience. 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 polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. 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). 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 Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. 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 The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or 806 report) in June 2021. 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. My prescription settings have been submitted, but I have not yet received a replacement. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. 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. 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. 303 0 obj
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. Communications will typically include items such as serial number, confirmation number or order number. Once your order is placed the order number will be listed in the Patient Portal. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. In this video, we will be going into detail about the process to register your device on the Philips website. You can log in or create one here. 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 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. Koninklijke Philips N.V., 2004 - 2023. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. I would like to learn more about my replacement device. Dont have one? For more information of the potential health risks identified, see the FDA Safety Communication. 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. 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. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . For further information about your current status, please log into the portal or call 877-907-7508. 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. 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. 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. You can create one here. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Please check the Patient Portal for updates. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. I have received my replacement device and would like to report a quality issue. Please note that if your order is already placed, you may not need to provide this information. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. We recommend you upload your proof of purchase, so you always have it in case you need it. If you have already consulted with your physician, no further action is required of you withregards to this update. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. 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. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. Philips Respironics continues to monitor recall awareness for affected patients [1]. Register your product and start enjoying benefits right away. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . 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. 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. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. 1. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. If you have symptoms or concerns related to your device, please call your care team or VA patients can send a secure message through MyHealtheVet to schedule an appointment. Selected products The .gov means its official.Federal government websites often end in .gov or .mil. The DME supplier can check to see if your device has been recalled. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. In the US, the recall notification has been classified by the FDA as a Class I recall. 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 did not include your email during registration, you can call us at +1-877-907-7508 to add your email. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. 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. Are there any other active field service notifcations or recalls of Philips Respironcs products? You are about to visit the Philips USA website. The silicone foam material used to replace the PE-PUR foam in the reworked ventilators may potentially move and block the airpath, which may reduce air flow in the ventilator and could also cause the device to alarm. 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. * This is a recall notification for the US only, and a field safety notice for the rest of the world. For further information about your current status, please log in to the. There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. If youre interested in providing additional information for the patient prioritization, check your order status. a. Then you can register your product. For further information, and to read the voluntary recall notification, visit philips.com/src-update. The data collected will be used to help to prioritize remediation of those patients at higher risk. The full report is available here. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. 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. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. To register your product, youll need to. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. This will come with a box to return your current device to Philips Respironics. 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. The site is secure. Call us at +1-877-907-7508 to add your email. Questions regarding registration, updating contact information (including address), or to cancel a registration. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . 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. They are undetectable after 24 hours of use. *. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. Didn't include your email during registration? We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. Follow the recommendations above for the recalled devices used in health care settings. No. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. 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