respironics recall registrationrespironics recall registration

The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Before sharing sensitive information, make sure you're on a federal government site. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. Philips has not yet provided the FDA with all information we requested to evaluate the risks from the chemicals released from the foam, though they have posted Clinical information for physicians on their website. 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). 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. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. 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. We may request contact information, date of birth, device prescription or physician information. 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. Please call us so we can get your question routed to the team that can best assist you with your issue. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. Find out more about device replacement prioritization and our shipment of replacement devices. Dont have one? The site is secure. For patients using life-sustaining ventilation, continue prescribed therapy. 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. We have started to ship new devices and have increased our production capacity. You are about to visit the Philips USA website. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. 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. 3. Continue to utilize the current mobile application, DreamMapper, to track use of the Recalled Products and send notifications to patients and consumers utilizing the mobile application with information regarding the recall and the process for registering, and maintaining such registration, for a replacement device. You can also visit philips.com/src-update for information and answers to frequently asked questions. 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. 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. Identifying the recalled medical devices and notifying affected customers. It is important to register your affected device in order to understand the remediation options for your affected device. 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. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. 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). 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. The full report is available here. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. 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. Before sharing sensitive information, make sure you're on a federal government site. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. No. 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 returned affected device will be repaired for another patient that is waiting within the replacement process. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. * This is a recall notification for the US only, and a field safety notice for the rest of the world. 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. visit VeteransCrisisLine.net for more resources. Although MDRs are a valuable source of information, this passive surveillance system has limitations. 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. a. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. 1. 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. 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. 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. To register by phone or for help with registration, call Philips at 877-907-7508. Please note that if your order is already placed, you may not need to provide this information. 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. 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. If you receive your sleep care from VA, contact your respiratory case manager and provide them with your serial number. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. Create account Create an account Already have an account? 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. Repairing and replacing the recalled devices. 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. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. Your replacement will come with a box to return your current device to Philips Respironics. The more we know about these devices the more research we can do.". Three types of devices have been recalled: 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 Trilogy 100 and Trilogy 200 ventilators. First, determine if you are using one of the affected devices. 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. 303 0 obj <>stream 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. 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. 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 Apologize for any inconvenience. The FDA has reached this determination based on an overall benefit-risk assessment. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. 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. 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). %PDF-1.7 % At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. 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. Learn more at www.vcf.gov . To register your product, youll need to log in to your My Philips account. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. I am experiencing technical issues with the Patient Portal. hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX h?>~LJ3AF E : 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. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. The data collected will be used to help to prioritize remediation of those patients at higher risk. Register your product and start enjoying benefits right away. By returning your original device, you can help other patients. 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. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. Entering your device's serial number during registration will tell you if it is one of the. Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. 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. Use another similar device that is not a part of this recall. Since April 2021, the FDA has received more than 98,000 MDRs, including 346 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown. 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. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. The full report is available here. 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 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). This recall will guide you through the registration process Machines and accessories that not. The WTC Health Program may be using one of the PE-PUR foam pieces collecting on the filter or problems. Your item or a pdf document from an online shop % gRRAHTx S4mXi # Kjbvy.MYZc >... 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