respironics recall registration

Eight of those reports were from the U.S. The full report is available here. 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. It is important to register your affected device in order to understand the remediation options for your affected device. Provide a link for health care providers and registrants to access all available testing results and third party confirmed conclusions on results and findings from testing PE-PUR foam used in devices manufactured by Philips for VOCs and particulates, regardless of the Philips device that the foam may have been tested in. Didn't include your email during registration? Philips Sleep and respiratory care. How can I tell if a recent call, letter or email is really from Philips Respironics? You are about to visit a Philips global content page. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. You are about to visit a Philips global content page. Following two rounds of comprehensive customer and patient outreach, Philips Respironics has reached the vast majority of the installed base in the US resulting in the registration of approximately 2.6 million devices in the country. Membership. . 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. Creating a plan to repair or replace recalled devices. 3. 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 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. The data collected will be used to help to prioritize remediation of those patients at higher risk. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. 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. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. 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. Medical guidance regarding this recall. 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. What information do I need to provide to register a product? 22 Questions This update provides additional information on the recall for people who use repaired and replaced devices. My prescription settings have been submitted, but I have not yet received a replacement. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. Your replacement device will include three key pieces of information, including how-to: Set up your device Clean and assemble existing components Return instructions. 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 are in crisis or having thoughts of suicide, 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. Log in 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. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) Once your order is placed the order number will be listed in the Patient Portal. Well reach out via phone or email with questions and you can always check your order status online. 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. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. hbbd``b` $@5HqXA5D4O"^ ar?O 1 + 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. Dont have one? Philips CPAP Recall Information. First, determine if you are using one of the affected devices. Foam: Do not try to remove the foam from your device. 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 . Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. 1. You can also upload your proof of purchase should you need it for any future service or repairs needs. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. Trying to or successfully removing the foam may damage the device or change how the device works. 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. 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. To access the menus on this page please perform the following steps. Repairing and replacing the recalled devices. For any therapy support needs or product questions please reach out hereto find contact information. I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. Devices need to be registered with Philips Respironics to receive a replacement device. According to Philips Respironics, as the foam breaks down gasses are emitted for about eight-hours of use. Contact and support for Philips Respironics voluntary recall Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. 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. 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. 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. At this time no serious adverse health events have been reported but Philips Respironics has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. The FDA developed this page to address questions about these recalls and provide more information and additional resources. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. 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 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. We will automatically match your registered device serial number back to our partner inventory registrations. No. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. Register your product and start enjoying benefits right away. endstream endobj startxref The FDA has reached this determination based on an overall benefit-risk assessment. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. The Clinical Centers of Excellence (CCEs) and the Nationwide Provider Network (NPN) are reviewing medical records and working with the Programs medical equipment providers to identify members using the recalled models. 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. We will automatically match your registered device serial number back to our partner inventory registrations. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. For more information of the potential health risks identified, see the FDA Safety Communication. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. Selected products In the US, the recall notification has been classified by the FDA as a Class I recall. We have started to ship new devices and have increased our production capacity. 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. At 877-907-7508 do not try to remove the foam from your device will be used to help to remediation. 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