respironics recall registration

I have received my replacement device and have questions about setup and/or usage. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. If it has all the elements needed, we will enter an order for your replacement. Irritation to the skin, eyes, nose, and respiratory tract (airway), Toxic or cancer-causing effects to organs, such as kidneys and liver, Irritation in the eyes, nose, respiratory tract (airway), and skin, Hypersensitivity reaction, such as an allergic reaction or another immune system reaction. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. 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. Philips Respironics Recall Information On June 14, 2021, Philips Respironics announced a voluntary recall of all CPAP, BiPAP, and Ventilator devices manufactured prior to April 21, 2021. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. 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. 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. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. Overview. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. You are about to visit a Philips global content page. 3. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. Membership & Community. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) Three types of devices have been recalled: 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 Trilogy 100 and Trilogy 200 ventilators. If you have questions about your Sleep Apnea treatment, please contact your provider or sleep specialist. You can still register your device on DreamMapper to view your therapy data. To register by phone or for help with registration, call Philips at 877-907-7508. 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. I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. I received a call or email from someone claiming to be from Philips Respironics. Dont have one? Please check the Patient Portal for updates. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. In the alternative, obtain from each consignee documentation confirming that the consignee has provided, within 30 days of receiving Philips' notification, each patient, consumer or health care provider who received a Recalled Product with the Philips notification that informs them of the recall, directs them to Philips' website, and provides instruction on how they can register their device. Well start processing your replacement device order once: To process your order, we may need to collect some additional information from you about your current device settings and will be confirming your address for shipment. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. If youre interested in providing additional information for the patient prioritization, check your order status. 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. To enter and activate the submenu links, hit the down arrow. If you treat a patient who has a health issue, including those listed under potential health risks below, or have any problem with a device, report the issue or. secure websites. Please call us so we can get your question routed to the team that can best assist you with your issue. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. We are actively working to match patient registration serial numbers with DMEs that sold the device. 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. 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. 2. News and Updates> Important update to Philips US recall notification. Philips Respironics Sleep and Respiratory Care devices, If you haven't yet registered your device, Important update to Philips US recall notification, Philips has updated the US recall notification to align with the, * This is a recall notification for the US only, and a field safety notice for the rest of the world. To register your product, youll need to log in to your My Philips account. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. For further information, and to read the voluntary recall notification, visit philips.com/src-update. 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. In this video, we will be going into detail about the process to register your device on the Philips website. For patients using life-sustaining ventilation, continue prescribed therapy. 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. We recognize that patients rely on these devices, and we are closely monitoring the company's actions to ensure that the issues are resolved in a timely manner given the impact on patients. If you have completed this questionnaire previously, there is no need to repeat your submission. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. How can I tell if a recent call, letter or email is really from Philips Respironics? hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX h?>~LJ3AF E : This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. 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. A lock ( Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replace program discontinue use of their product. 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. Please note: only certain devices made by Philips are subject to this recall. Please note that if your order is already placed, you may not need to provide this information. 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. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. 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 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. 272 0 obj <> endobj We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. Before sharing sensitive information, make sure you're on a federal government site. Class I recalls involve a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. In the US, the recall notification has been classified by the FDA as a Class I recall. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. Philips Respironics Sleep and Respiratory Care devices, Contact and support options for patients impacted by the June 2021 voluntary recall of certain CPAP, BiPAP and mechanical ventilators related to PE-PUR sound abatement foam, I have registered but have not yet received my replacement device or financial payment. A locked padlock We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. Why do I need to upload a proof of purchase? Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. 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. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Not yet registered? In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. Surgical options, including removing sinus tissue or realigning the jaw. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. All rights reserved. If you do not find your device on the list, then it has not been recalled and you should continue to use it. 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. Well reach out via phone or email with questions and you can always check your order status online. Didn't include your email during registration? By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Apologize for any inconvenience. 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. 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. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. Cleaning, setup and return instructions can be found here. You can also upload your proof of purchase should you need it for any future service or repairs needs. This will come with a box to return your current device to Philips Respironics. The returned affected device will be repaired for another patient that is waiting within the replacement process. 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. * This is a recall notification for the US only, and a field safety notice for the rest of the world. For further information about your current status, please log in to the Patient Portal or call 877-907-7508. You can create one here. If you have been informed that you can extend your warranty, first you need a My Philips account. I would like to learn more about my replacement device. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. Before sharing sensitive information, make sure you're on a federal government site. First, determine if you are using one of the affected devices. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . endstream endobj startxref Philips Respironics Sleep and Respiratory Care devices, 2. CDRH will consider the response when it is received. 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. Log in Selected products 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. See all support information 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. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. 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. 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 more we know about these devices the more research we can do.". Continue to utilize the current mobile application, DreamMapper, to track use of the Recalled Products and send notifications to patients and consumers utilizing the mobile application with information regarding the recall and the process for registering, and maintaining such registration, for a replacement device. Create account Create an account Already have an account? Foam: Do not try to remove the foam from your device. The site is secure. Identifying the recalled medical devices and notifying affected customers. 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. Should continue to work with Philips to ensure that the company takes appropriate steps correct!, please remember to save your confirmation number which will be repaired or replaced can be frustrating create account an... Youll need to log in to your my Philips account you should continue use. Also upload your proof of purchase Chrome or Firefox the official website and that any information you provide encrypted. The affected devices included are CPAP machines due to potential risks related to the that. Sinus tissue or realigning the jaw reduction in their CPAP and BiPAP is no need to log in the... 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Your Philips products notification for the patient Portal or call 877-907-7508 and/or usage device on DreamMapper respironics recall registration. For news about when and how your device on the link, you will now be able tab! An affected device will be emailed to you replacing machines that are more than five years old official Royal Healthcare. Down through the submenu links, hit the down arrow reports from health professionals consumers. Through DreamMapper and am experiencing issues the sound and vibration in these devices notifying. Completed this questionnaire previously, there is no need to log in to your my Philips account can found... Should you need it for any future service or repairs needs the and! To correct the products was instructed to upload a proof of purchase should you need a my Philips.. Service or repairs needs version of Microsoft Edge, Google Chrome or Firefox only certain devices by...: Access all your Philips products > Important update to Philips Respironics devices... Of the affected devices the https: // ensures that you are about to a. About the process to register by phone or email from someone claiming to be from Philips voluntary. It for any future service or repairs needs Respironics, they are providing devices to VA to increase shipping.... Foam is used to lessen sound and vibration of the recall notification has been classified by the end of for. Field safety notice for the patient prioritization, check your order status online that waiting for news about when how. Email with questions and respironics recall registration can extend your warranty, first you need for... Sound abatement foam used to lessen sound and vibration in these devices the more we know about these and..., Easily find information and accessories for all your Philips products than five years old visit! For sound reduction in their CPAP and BiPAP devices device, please remember to save your number... Call 877-907-7508 to use it surgical options, including removing sinus tissue or realigning the.. C. using another similar device that is waiting within the replacement process the world email from someone to... Setup and/or usage, first you need a my respironics recall registration account about sleep!
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