respironics recall registrationnicknames for the name memphis
The full report is available here. An official website of the United States government. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Please check the Patient Portal for updates. 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. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. Please note that if your order is already placed, you may not need to provide this information. Before sharing sensitive information, make sure you're on a federal government site. A .gov website belongs to an official government Do not use ozone or ultraviolet (UV) light cleaners. 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. 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. We will keep the public informed as more information becomes available. I registered my affected device, but have not heard anything further about my replacement. There are no updates to this guidance. 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. hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX h?>~LJ3AF E : Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. How can I register my product for an extended warranty? There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. 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 will not ask you to return your recalled device until after you receive the replacement. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. If you have already consulted with your physician, no further action is required of you withregards to this update. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for 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. 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. Be cautious as they may be scams! More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. the .gov website. The PE-PUR foam used in the recalled devices may break down and can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. These Philips Trilogy 100 and Trilogy 2000 ventilators were a part of this recall in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. 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. 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. Then you can register your product. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. The relevant heath information that will be asked includes: An occupation associated with public safety. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . 2. 0 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. 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. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. Is there a question we can answer for you? 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. 1. To register a new purchase, please have the product on hand and log into your My Philips account. Koninklijke Philips N.V., 2004 - 2023. 2. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices 3,950,000 repair kits and replacement devices produced to date globally 2,000,000 devices shipped in the US Communications will typically include items such as serial number, confirmation number or order number. It may also lead to more foam or chemicals entering the air tubing of the device. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. 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. 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. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. The foam cannot be removed without damaging the device. We are actively working to match patient registration serial numbers with DMEs that sold the device. You are about to visit a Philips global content page. Find out more about device replacement prioritization and our shipment of replacement devices. 3. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. 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 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. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. visit VeteransCrisisLine.net for more resources. 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. For patients using life-sustaining ventilation, continue prescribed therapy. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. Positional therapy, such as elevating the head of your bed, using a device that prevents you from turning to your side or back, or avoiding sleeping on your back. 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. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. 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. 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 known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines. 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: . Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). 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. Dont have one? This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. You can create one here. Keep your registration confirmation number. 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. Trying to or successfully removing the foam may damage the device or change how the device works. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. Only clean your device according to the manufacturers recommendations. If you have a health issue, including any of the health issues listed above, or any problem with your device, the FDA encourages you to talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. CDRH will consider the response when it is received. How can I tell if a recent call, letter or email is really from Philips Respironics? Veterans Crisis Line: To register your product, youll need to log in to your My Philips account. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. See the FDA Safety Communication for more information. Images may vary. 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. The site is secure. 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 Have the product at hand when registering as you will need to provide the model number. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. We are investigating potential injury risks to users, including several cancers. 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. 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). Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. I have received my replacement device and would like to report a quality issue. We have started to ship new devices and have increased our production capacity. You are about to visit a Philips global content page. If you have completed this questionnaire previously, there is no need to repeat your submission. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). If you have symptoms or concerns related to your device, please call your care team or VA patients can send a secure message through MyHealtheVet to schedule an appointment. You can log in or create one here. You may or may not see black pieces of the foam in the air tubes or masks. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. We may need more information from you or you may have other options available to you, including alternative replacement devices or financial payment, dependent on your specific situation. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Provided by Philips to the manufacturers recommendations provide this information your health care provider to decide if plan. And mechanical ventilator devices register your product, youll need to repeat your submission, with... 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