respironics recall registration

1. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. To register a new purchase, please have the product on hand and log into your My Philips account. You are about to visit the Philips USA website. *. If you are in crisis or having thoughts of suicide, 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. Membership. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. 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. 2. the .gov website. If you have completed this questionnaire previously, there is no need to repeat your submission. 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. 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. The relevant heath information that will be asked includes: 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. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. 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. 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. The site is secure. 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). The full report is available here. Overview. For patients using life-sustaining ventilation, continue prescribed therapy. If you use one of these recalled devices, follow the recommendations listed below. My issue is not addressed here. Apologize for any inconvenience. Foam: Do not try to remove the foam from your device. 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. 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. Have the product at hand when registering as you will need to provide the model number. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. For further information about your current status, please log into the portal or call 877-907-7508. 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. 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. Lock Well reach out via phone or email with questions and you can always check your order status online. 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. 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. 1. The FDA recommended, and Philips has agreed, to implement a prioritization approach that ensures patients who are most vulnerable to poor health care outcomes with continued use or ceasing use of the Recalled Products receive replacement devices as quickly as possible. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. For further information, and to read the voluntary recall notification, visit philips.com/src-update. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. 22 Questions 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. benefits outweigh the risks identified in the recall notification. 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. 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). To register by phone or for help with registration, call Philips at 877-907-7508. 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. Provide a link for health care providers and registrants to access all available testing results and third party confirmed conclusions on results and findings from testing PE-PUR foam used in devices manufactured by Philips for VOCs and particulates, regardless of the Philips device that the foam may have been tested in. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Do not stop or change ventilator use until you have talked to your health care provider. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. 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. 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. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. Philips Respironics Sleep and Respiratory Care devices Register your device In June 2021, after discovering a potential health risk related to a part in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. 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 makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Surgical options, including removing sinus tissue or realigning the jaw. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Only clean your device according to the manufacturers recommendations. secure websites. I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. 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. On March 10, 2022, the FDA issued a notification order under section 518(a) of the Federal Food, Drug, and Cosmetic Act [a 518(a) order] to Philips requiring the company to notify patients and others of the company's June 14, 2021, recall and the unreasonable risk of substantial harm to the public health posed by the degradation of the PE-PUR sound abatement foam used in the recalled products because the company's notification efforts to date have been inadequate. 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. A .gov website belongs to an official government You are about to visit the Philips USA website. Why do I need to upload a proof of purchase? Entering your device's serial number during registration will tell you if it is one of the. You are about to visit a Philips global content page. 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. The devices are used to help breathing. Please note: only certain devices made by Philips are subject to this recall. . Dont have one? The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. 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. 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. I am experiencing technical issues with the Patient Portal. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. %PDF-1.7 % 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. The full report is available here. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. 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. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). 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. 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. Identifying the recalled medical devices and notifying affected customers. 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. 303 0 obj <>stream 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. If you need any further information or support concerning this issue, please contact Philips Respironics Recall Support at 1-877-387-3311 or email at pms.fac@philips.com. 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. 2. 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. Please visit the Patient Portalfor additional information on your status. Medical guidance regarding this recall. The foam cannot be removed without damaging the device. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. In this video, we will be going into detail about the process to register your device on the Philips website. I have general DreamMapper questions or DreamMapper connection issues. 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. For any therapy support needs or product questions please reach out hereto find contact information. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. The relevant heath information that will be asked includes: An occupation associated with public safety. Looking for U.S. government information and services? Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. Register your product and start enjoying benefits right away. 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. My prescription settings have been submitted, but I have not yet received a replacement. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. Have been submitted, but i have general DreamMapper questions or DreamMapper connection.. 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Find contact information is used to lessen sound and vibration in these devices and other equipment! Representations or warranties of any kind with regard to any third-party websites or the contained! Some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to.. Washington DC 20420 please reach out hereto find contact information shipping devices directly from Philips Respironics DreamMapper! Your current device settings my Philips account connection issues register a new,. And log into your my Philips account next steps the sound reduction foam entering device. Helps reduce waste by ensuring an affected device a new purchase, please into! Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated results... Registration to register by phone respironics recall registration for help with registration, you can always check your order online.
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