If we cannot find a match, we may reach out to you for additional information. Communications will typically include items such as serial number, confirmation number or order number. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. How can I tell if a recent call, letter or email is really from Philips Respironics? For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. To decide on the next steps, discuss the benefits and risks based on your individual health situation with your health care provider, such as your primary care physician or sleep doctor. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. If you use one of these recalled devices, follow the recommendations listed below. A .gov website belongs to an official government Philips Respironics created an online registration process to allow patients to look up their device serial number . 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. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. An official website of the United States government. Very small particles from the foam could break lose and come through the air hose. I registered my affected device, but have not heard anything further about my replacement. Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. Identifying the recalled medical devices and notifying affected customers. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. The FDA recognizes that many patients have questions about what this information means for the status of their devices. If you are in crisis or having thoughts of suicide, This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. For patients using life-sustaining ventilation, continue prescribed therapy. Register your product and start enjoying benefits right away. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. We are working with several partners to improve responsiveness and we are using their email domain names in some communications, including: Koninklijke Philips N.V., 2004 - 2023. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. CHEST Issues Joint Statement in Response to Philips Device Recall . We recommend you upload your proof of purchase, so you always have it in case you need it. For patients using life-sustaining ventilation, continue prescribed therapy. Attention A T users. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. In the US, the recall notification has been classified by the FDA as a Class I recall. %%EOF Home | Philips Recall (expertinquiry.com), Philips Frequently Asked Questions (FAQ) Web Version, Philips Frequently Asked Questions (FAQ) PDF Version, FDA: Philips Respironics CPAP Machine Recall Announcement. 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. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. 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. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . 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. Please visit the Patient Portalfor additional information on your status. 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. 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. Creating a plan to repair or replace recalled devices. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices Sign in now New to My Philips? Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. Philips Respironics states that the likelihood of foam breakdown is higher in devices that are more than three years old, are used in high heat (more than 95 degrees) and high humidity environments or that were routinely cleaned with an ozone cleaning device. 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 By returning your original device, you can help other patients. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand *. 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. Lifestyle Measures to Manage Sleep Apnea fact sheet. 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. We have started to ship new devices and have increased our production capacity. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. Keep your registration confirmation number. The full report is available here. secure websites. 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. Philips Respironics has issued a . 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. If you no longer use your recalled device, return it to Philips by contacting Philips, your local Philips representative, durable medical equipment (DME) supplier, or pharmacy for instructions and directions on how to return your recalled device. 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. To access the menus on this page please perform the following steps. 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. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. 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. 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. 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. 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. Philips CPAP Recall Information. We will keep the public informed as more information becomes available. 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 . Koninklijke Philips N.V., 2004 - 2023. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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: . 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. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. The FDA's evaluation of the information provided by Philips is ongoing. Is there a question we can answer for you? Register your product and start enjoying benefits right away. 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. The returned affected device will be repaired for another patient that is waiting within the replacement process. Dont have one? Questions regarding registration, updating contact information (including address), or to cancel a registration. You are about to visit a Philips global content page. The DME supplier can check to see if your device has been recalled. No. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. There are no updates to this guidance. Repairing and replacing the recalled devices. Once your order is placed the order number will be listed in the Patient Portal. I received a call or email from someone claiming to be from Philips Respironics. Matching your registration to your Durable Medical Equipment provider (DME), Find out if your device is matched to a DME registration, Your device registration is matched to your DME, Please contact the Philips Customer Service team directly on. Apologize for any inconvenience. b. Philips did not request a hearing at this time but has stated it will provide a written response. Koninklijke Philips N.V., 2004 - 2023. 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 If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. Consult with your physician as soon as possible to determineappropriate next steps. There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. You can also upload your proof of purchase should you need it for any future service or repairs needs. 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. 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. 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. Before sharing sensitive information, make sure you're on a federal government site. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. 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. The FDA is ordering Philips Respironics to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care providers who prescribe the products about. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. 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. Not yet registered? Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. Koninklijke Philips N.V., 2004 - 2023. 3. We will automatically match your registered device serial number back to our partner inventory registrations. I would like to learn more about my replacement device. 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. 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. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. 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. Read the FDA's recommendations for using the following types of devices: Talk to your health care provider to decide whether it is better to stop using your device, use other treatments, or continue using your recalled device while waiting for a replacement or repair. All rights reserved. Dont have one? Philips Respironics Sleep and Respiratory Care devices, 2. Didn't include your email during registration? We are investigating potential injury risks to users, including several cancers. 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. Please call us so we can get your question routed to the team that can best assist you with your issue. 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. 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. 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. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. 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. Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. If you do not find your device on the list, then it has not been recalled and you should continue to use it. Communications will typically include items such as serial number, confirmation number or order number. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. 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. endstream endobj startxref Can we help? 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. 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. 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