respironics recall registration

Access all your product information in one place (orders, subscriptions, etc. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. 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. For further information about your current status, please log in to the. 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. 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. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. 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. 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. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. benefits outweigh the risks identified in the recall notification. 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. 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 devices are used to help breathing. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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 . Trying to or successfully removing the foam may damage the device or change how the device works. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. Dont have one? In the US, the recall notification has been classified by the FDA as a Class I recall. 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. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. . 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). You can also visit philips.com/src-update for information and answers to frequently asked questions. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or 806 report) in June 2021. We will keep the public informed as more information becomes available. Once your order is placed the order number will be listed in the Patient Portal. To register by phone or for help with registration, call Philips at 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. Creating a plan to repair or replace recalled devices. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. 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. Please note that if your order is already placed, you may not need to provide this information. You can also upload your proof of purchase should you need it for any future service or repairs needs. 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. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. See the FDA Safety Communication for more information. We will automatically match your registered device serial number back to our partner inventory registrations. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. 0 CHEST MEMBERSHIP About Membership . 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. 2. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. 1. You are about to visit a Philips global content page. Medical guidance regarding this recall. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Didn't include your email during registration? The FDA has worked with patients and health care professional organizations, including the American Sleep Apnea Association, the COPD (chronic obstructive pulmonary disease) Foundation, the Muscular Dystrophy Association, the Mended Hearts, Inc., American College of Chest Physicians, American Thoracic Society, and the American Academy of Sleep Medicine, and has included this feedback in these FAQs. Find out more about device replacement prioritization and our shipment of replacement devices. Didn't include your email during registration? 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. No. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. For any therapy support needs or product questions please reach out hereto find contact information. You can also upload your proof of purchase should you need it for any future service or repairs needs. *. CHEST Issues Joint Statement in Response to Philips Device Recall . 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. 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. 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. 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. The FDA developed this page to address questions about these recalls and provide more information and additional resources. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. ) or https:// means youve safely connected to You are about to visit the Philips USA website. 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. 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. For patients using life-sustaining ventilation, continue prescribed therapy. If you do not find your device on the list, then it has not been recalled and you should continue to use it. We understand this can be concerning and want to remind you of the following ways you can confirm whether a contact is from Philips Respironics: @philips.com for 1:1 customer service communications @zixmessaging.com for secure transfer of prescription information @sedgwick.com for monthly updates, @philips.com for 1:1 customer service communications, @zixmessaging.com for secure transfer of prescription information. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. Do not use ozone or ultraviolet (UV) light cleaners. 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. The FDA recognizes that many patients have questions about what this information means for the status of their devices. If you receive your sleep care from VA, contact your respiratory case manager and provide them with your serial number. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. 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. 1. Please check the Patient Portal for updates. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. 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. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. Call us at +1-877-907-7508 to add your email. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. All rights reserved. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. You can also visit philips.com/src-update for information and answers to frequently asked questions. News and Updates> Important update to Philips US recall notification. a. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. 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. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices Sign in now New to My Philips? Please visit the Patient Portalfor additional information on your status. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. The potential health risks from the foam are described in the FDA's safety communication. If youre interested in providing additional information for the patient prioritization, check your order status. As noted in the FDA inspectional observations in November 2021, an incorrect and non-specified polyester polyurethane, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain Trilogy Evo ventilators. 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. I have received my replacement device and have questions about setup and/or usage. 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. 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. Provide respironics recall registration with your physician on a suitable treatment plan will be listed in the FDA recognizes many. Out to some patients via email, mail and phone and will keep public... Work with other manufacturers and government partners to determine the best way to or. 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