respironics recall registrationrespironics recall registration

We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. 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. You may or may not see black pieces of the foam in the air tubes or masks. Please switch auto forms mode to off. The foam cannot be removed without damaging the device. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. Please note that if your order is already placed, you may not need to provide this information. Koninklijke Philips N.V., 2004 - 2023. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. Our Prescription Team is required to review all prescriptions. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. 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. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. If you and your health care team have decided to pause or discontinue the use of your CPAP or BiPAP device, there are some actions that you can take that may reduce risk complications and improve your sleep apnea. We recommend you upload your proof of purchase, so you always have it in case you need it. 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. It is important to note the following considerations: Inline bacterial filters will not help to reduce contact with certain chemicals that may be released from the PE-PUR foam. The data collected will be used to help to prioritize remediation of those patients at higher risk. We recommend you upload your proof of purchase, so you always have it in case you need it. Can we help? A locked padlock 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. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. 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. You can create one here. 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. Before sharing sensitive information, make sure you're on a federal government site. 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. Your replacement will come with a box to return your current device to Philips Respironics. Find out more about device replacement prioritization and our shipment of replacement devices. You can create one here. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. 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. 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. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. 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. 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. Share sensitive information only on official, This will come with a box to return your current device to Philips Respironics. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, How to Tell if Your Device Has Been Recalled and What to Do Next, How to Know if You Should Stop Using Your Device, What to Do with Your Device: Cleaners, Filters, Foam, Returns, Philips' Recalls Not Associated with the Foam Issue, How to Report a Health Issue or Problem to the FDA, FDA Safety Communication: Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, How to Locate the Serial Number on your device, report the problem through the FDA's MedWatch Voluntary Reporting Form, Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories, recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam, requested that Philips retain an independent laboratory to perform additional testing of the silicone-based foam, Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices, Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern, Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms, Philips Respironics Recalls V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm, Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen, report the problem through the MedWatch Voluntary Reporting Form, Philips' medical device recall information page. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. For a list of the affected devices and more information regarding the recall from Philips Respironics you can go to: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateChapters:00:00 Intro00:44 Find Your Serial Number01:49 Online Form06:05 Demand for CPAP MachinesShop Online: Our Store: https://sleeplay.comCPAP Machines: https://sleeplay.com/collections/cpap-machinesCPAP Masks: https://sleeplay.com/collections/cpap-masksCPAP Cleaning: https://sleeplay.com/collections/cpap-cleaningCPAP Supplies: https://sleeplay.com/collections/cpap-suppliesOxygen Therapy: https://sleeplay.com/collections/oxygen-therapyGo Social:Facebook: https://facebook.com/sleeplaygroundInstagram: https://instagram.com/sleeplaygroundTwitter: https://twitter.com/sleeplayground TikTok: https://tiktok.com/@sleeplaygroundBecome an Affiliate:https://sleeplay.refersion.com/affiliate/registrationFree Consultation:https://calendly.com/sleeplay/respiratory-therapist-consultation This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. Lock More information on. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. Koninklijke Philips N.V., 2004 - 2023. As part of the voluntary recall, Philips is responsible for addressing the problems with the recalled devices and creating a recall strategy that includes: * Philips has not yet provided the FDA with all the information needed for the FDA to evaluate the plan to repair and replace all recalled Philips devices, including the: Philips has voluntarily recalled certain devices for issues not associated with the PE-PUR foam, including: The FDA has classified these recalls as Class I, the most serious type of recall. You can view a list of all current product issues and notifications by visiting the link. Office of Accountability & Whistleblower Protection, Training - Exposure - Experience (TEE) Tournament, Chief Resident in Quality and Patient Safety, About the National Center for Patient Safety, War Related Illness & Injury Study Center, Clinical Trainees (Academic Affiliations), https://www.philipssrcupdate.expertinquiry.com, Call TTY if you 2. First, determine if you are using one of the affected devices. The .gov means its official.Federal government websites often end in .gov or .mil. * This is a recall notification for the US only, and a field safety notice for the rest of the world. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. 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. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. hbbd``b` $@5HqXA5D4O"^ ar?O 1 + How can I tell if a recent call, letter or email is really from Philips Respironics? Do not stop or change ventilator use until you have talked to your health care provider. kidneys and liver) and carcinogenic effects. 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. To register a new purchase, please have the product on hand and log into your My Philips account. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. If you use one of these recalled devices, follow the recommendations listed below. Veterans Crisis Line: In this video, we will be going into detail about the process to register your device on the Philips website. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. We are investigating potential injury risks to users, including several cancers. The site is secure. Medical guidance regarding this recall. Once your order is placed the order number will be listed in the Patient Portal. 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. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. 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. 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. Membership. The foam was determined to be PE-PUR foam, the same type of foam used in Philips' devices previously recalled in June 2021. In the US, the recall notification has been. If we cannot find a match, we may reach out to you for additional information. Be PE-PUR foam, the same type of foam used in Philips ' instructions and recommended cleaning and replacement for! 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