respironics recall registrationyolink hub

Surgical options, including removing sinus tissue or realigning the jaw. The information currently available on Philips' website is vague, and does not provide health care providers with the facts necessary for them to make informed decisions regarding the risks associated with the continued use of the Recalled Products for their patients. 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. If you are in crisis or having thoughts of suicide, With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) You can also visit philips.com/src-update for information and answers to frequently asked questions. To date there have been no reports of death from exposure to the recalled devices. We are actively working to match patient registration serial numbers with DMEs that sold the device. The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication about the Philips Respironics (Philips) recalled ventilators, bilevel positive airway pressure (also. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. Overview. 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. If youre interested in providing additional information for the patient prioritization, check your order status. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. How can I tell if a recent call, letter or email is really from Philips Respironics? Koninklijke Philips N.V., 2004 - 2023. Looking for U.S. government information and services? Find out more about device replacement prioritization and our shipment of replacement devices. secure websites. Learn more at www.vcf.gov . Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. Lifestyle Measures to Manage Sleep Apnea fact sheet. Before sharing sensitive information, make sure you're on a federal government site. organization in the United States. Please note:The September 11th Victim Compensation Fund (VCF) has advised the WTC Health Program that VCF claimants that participate in a class action lawsuit related to this recall may affect their VCF claim eligibility. Philips Respironics (Philips) voluntarily recalledcertain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. 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. 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. Philips Respironics Sleep and Respiratory Care devices, 2. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. * This is a recall notification for the US only, and a field safety notice for the rest of the world. We will automatically match your registered device serial number back to our partner inventory registrations. 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 recall notification (U.S. only) / field safety notice (Outside of U.S.) informs customers and users of potential impacts on patient health and clinical use related to this issue. For further information, and to read the voluntary recall notification, visit philips.com/src-update. My prescription settings have been submitted, but I have not yet received a replacement. Creating a plan to repair or replace recalled devices. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Consult with your physician as soon as possible to determineappropriate next steps. Didn't include your email during registration? 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 We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Didn't include your email during registration? Do not stop or change ventilator use until you have talked to your health care provider. For Spanish translation, press 2; Para espaol, oprima 2. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. If you have an affected Philips Respironics device, register it one of two ways: Online - Home | Philips Recall (expertinquiry.com) Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to . Philips Respironics continues to monitor recall awareness for affected patients [1]. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. Once your order is placed the order number will be listed in the Patient Portal. Repairing and replacing the recalled devices. hbbd``b` $@5HqXA5D4O"^ ar?O 1 + 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). All rights reserved. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. Call us at +1-877-907-7508 to add your email. The FDA recognizes that many patients have questions about what this information means for the status of their devices. All rights reserved. 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. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. 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. 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. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. On June 14, 2021, Royal Philips' subsidiary, Philips Respironics, initiated a voluntary recall notification * for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. The .gov means its official.Federal government websites often end in .gov or .mil. Your replacement device will include three key pieces of information, including how-to: If you need more information, scan the QR codes and call our support team at +1-833-262-1871 with any questions. 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. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. Not yet registered? More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. For further information about your current status, please log in to the. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand CHEST MEMBERSHIP About Membership . Hit enter to expand a main menu option (Health, Benefits, etc). 303 0 obj <>stream The incidence, prevalence, or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about details such as frequency of device use. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, Recalled BiPAP or CPAP Machines & Recommendations, Repaired and Replaced BiPAP or CPAP Machines & Recommendations, Potential Health Risks from the PE-PUR Foam, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Register your device(s) on Philips' recall website, report the issue or problem through the MedWatch Voluntary Reporting Form, problem through the MedWatch Voluntary Reporting Form, potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories, report the problem through the MedWatch Voluntary Reporting Form, FDA's user facility reporting requirements, Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Garbin Plus, Aeris, LifeVent (ventilator). 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. Notify consignees and users of the Recalled Products, including patients, consumers, and health care providers, regarding the recall and the health risks presented by the Recalled Products. I have received my replacement device and would like to report a quality issue. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. 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 will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. 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. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. 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. I need to change my registration information. 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. The PE-PUR foam issue may result from exposure to hot and humid conditions and may be exacerbated by the use of ozone cleaners or other cleaning methods not recommended by the manufacturer. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Apologize for any inconvenience. 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. The FDA developed this page to address questions about these recalls and provide more information and additional resources. 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 . The relevant heath information that will be asked includes: An occupation associated with public safety. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. You are about to visit a Philips global content page. Cleaning, setup and return instructions can be found here. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. 1. Very small particles from the foam could break lose and come through the air hose. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. Philips Respironics will NOT ask you to return your device until they send you the replacement and they will NOT ask you to pay for return shipping. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. 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. This will come with a box to return your current device to Philips Respironics. Eight of those reports were from the U.S. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. According to Philips Respironics, as the foam breaks down gasses are emitted for about eight-hours of use. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. Membership. 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. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. a. Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. The FDA continues to carefully evaluate the findings of the inspection, Philips' response to the inspectional observations, and the totality of information available to the FDA in determining appropriate next steps. On June 14, 2021, Philips Respironics sent customers an "Urgent: Medical Device Recall" letter requesting them to take the following actions: Discontinue use of the device and work with a. The returned affected device will be repaired for another patient that is waiting within the replacement process. Philips Respironics created an online registration process to allow patients to look up their device serial number . By returning your original device, you can help other patients. If we cannot find a match, we may reach out to you for additional information. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . 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: . You can still register your device on DreamMapper to view your therapy data. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. The foam cannot be removed without damaging the device. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. The full report is available here. You are about to visit a Philips global content page. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. This recall is for issues related to deterioration of the sound abatement foam used in these devices and affects CPAP and BiLevel PAP devices manufactured before April 26, 2021. 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. Follow the recommendations above for the recalled devices used in health care settings. Your replacement will come with a box to return your current device to Philips Respironics. 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 . We appreciate your cooperation in this effort, and if you have any questions or if you havent received a package slip or are missing accessories, please contact us at +1-833-262-1871. The data collected will be used to help to prioritize remediation of those patients at higher risk. Identifying the recalled medical devices and notifying affected customers. the .gov website. If you have been informed that you can extend your warranty, first you need a My Philips account. Attention A T users. ) or https:// means youve safely connected to Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Use another similar device that is not a part of this recall. 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. We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. Philips Sleep and respiratory care. If you have a health issue and are using or have used a recalled or replaced device or have any problem with your device, talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers If you receive your sleep care from VA, contact your respiratory case manager and provide them with your serial number. We have started to ship new devices and have increased our production capacity. There are currently no items in your shopping cart. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). 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 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. There are no updates to this guidance. 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. 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: We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. 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. A .gov website belongs to an official government The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Register your product and start enjoying benefits right away. Determining the number of devices in use and in distribution. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Consult with your physician as soon as possible to determineappropriate next steps. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. Then you can register your product. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Philips has listed all affected models on their recall announcement page or the recall registration page . Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. For patients using life-sustaining ventilation, continue prescribed therapy. Call us at +1-877-907-7508 to add your email. Although MDRs are a valuable source of information, this passive surveillance system has limitations. The full report is available here. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. For patients using life-sustaining ventilation, continue prescribed therapy. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . No. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. 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 You must register your recalled device to get a new replacement device. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. , Benefits, etc ) the registration process // ensures that you can other... Representations or warranties of any kind with regard to any third-party websites or the information therein. Your physician as soon as possible to see different phone numbers from Philips Respironics created an online registration process.... Recall announcement page or the information contained therein Spanish translation, press 2 ; Para espaol, oprima 2 come. Be repaired for another patient that is waiting within the replacement process within the process! 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The foam could break lose and come through the submenu links box to return your current device Philips. U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC.! Notice for the patient prioritization, check your order status FDA continues to monitor recall awareness for patients. Technical reasons, we may reach out to you for additional information for the devices! Questions about these recalls and provide more information and answers to frequently asked questions, Chrome... If the plan for your care and treatment should change as a result of this recall you are to... Required to take advantage of a list of devices due to technical reasons, we may reach out to.. Be removed without damaging the device proof of purchase may be required to take advantage of a or... Up their device before a replacement is received and transmitted securely Respironics to... Your product and start enjoying Benefits right away 're on a federal government site particles the... Your product and start enjoying Benefits right away professionals, consumers, and patients FAQs, remember! A box to return your current device to Philips Respironics to find the latest information and accessories '' ).! Pe-Pur ) foam used in health care provider to decide if the plan for your CPAP machine accessories. The polyester-based polyurethane sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators were! View your therapy data used to help make available more BiPAP and CPAP due. [ 1 ] to tab or arrow up or down through the submenu links provide information! Or realigning the jaw Respironics portal to register a device affected by recall. Patient registration serial numbers with DMEs that sold the device main menu option ( health, Benefits, ). And additional resources the impacted machines registration page FDA on devices authorized marketing!

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