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. If you have any concerns we suggest you contact your durable medical equipment provider or your sleep specialist.Per Philips Respironics, all patients using one of their PAP devices should discontinue use immediately due to the health risks. Entering your device's serial number during registration will tell you if it is one of the. 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. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). The site is secure. My prescription settings have been submitted, but I have not yet received a replacement. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. 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. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. On May 2, 2022, the FDA's Center for Devices and Radiological Health (CDRH) sent notice to Philips that CDRH is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act [a 518(b) order], to require Philips to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after November 2015. endstream endobj startxref Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Dont have one? 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. Consult with your physician as soon as possible to determineappropriate next steps. Secure .gov websites use HTTPS Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. There are no updates to this guidance. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. An official website of the United States government. Your replacement will come with a box to return your current device to Philips Respironics. %%EOF 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. The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. Steps to return your affected device: By returning your original device, you can help other patients. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. More information is available at http://www.philips.com/src-update. More information on. Official websites use .gov You can also visit philips.com/src-update for information and answers to frequently asked questions. Create account Create an account Already have an account? 2. Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. 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. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. have hearing loss. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. 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: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. You are about to visit a Philips global content page. 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. I registered my affected device, but have not heard anything further about my replacement. This will come with a box to return your current device to Philips Respironics. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. We are investigating potential injury risks to users, including several cancers. If you are in crisis or having thoughts of suicide, Foam: Do not try to remove the foam from your device. 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. For further information about your current status, please log in to the Patient Portal or call 877-907-7508. Philips may implement the mandated notification to patients, health care providers and consumers in the following ways: Request each consignee to provide Phillips with contact information for each patient, consumer or health care provider who received a Recalled Product, and then contact those patients and consumers within 30 days of receiving their contact information to inform them of the recall, direct them to the Philips website, and provide instructions on how they can register their device. Register your product and start enjoying benefits right away. To access the menus on this page please perform the following steps. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. That will allow them place an order for your supplies. hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX h?>~LJ3AF E : 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. Find out more about device replacement prioritization and our shipment of replacement devices. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. 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. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. 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. 3. Communications will typically include items such as serial number, confirmation number or order number. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. We have started to ship new devices and have increased our production capacity. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. Philips may contact some patients via phone and ask for their physician's contact information, and then Philips will contact the physician directly so that the prescription can be sent to the contact information below: Tel: 1-857-758-7090 Fax: 1-331-233-0129 Email: [email protected] PAP Recall 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. You can also upload your proof of purchase should you need it for any future service or repairs needs. Learn more about the recall Begin registration process 877-907-7508 * This is a recall notification for the US only, and a field safety notice for the rest of the world. They are undetectable after 24 hours of use. For further information about your current status, please log into the portal or call 877-907-7508. To register by phone or for help with registration, call Philips at 877-907-7508. 2. This update provides additional information on the recall for people who use repaired and replaced devices. 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. 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. There are no updates to this guidance. If we cannot find a match, we may reach out to you for additional information. The returned affected device will be repaired for another patient that is waiting within the replacement process. 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. 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 will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. If it has all the elements needed, we will enter an order for your replacement. The .gov means its official.Federal government websites often end in .gov or .mil. We will automatically match your registered device serial number back to our partner inventory registrations. At this time, the FDA has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. 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 note that if your order is already placed, you may not need to provide this information. I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. 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. Be cautious as they may be scams! 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. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . *The number of deaths has been updated to reflect Philips retrospective review of MDRs. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. Apologize for any inconvenience. Didn't include your email during registration? 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. All rights reserved. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . Philips Respironics created an online registration process to allow patients to look up their device serial number . If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. Understand how were handling the recall and know what to expect, We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. Philips has listed all affected models on their recall announcement page or the recall registration page. First, determine if you are using one of the affected devices. Access all your product information in one place (orders, subscriptions, etc. 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. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Manufacturers, such as Philips, are required to submit medical device reports (MDRs) when they become aware of an event that reasonably suggests that one of their devices may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. The FDA developed this page to address questions about these recalls and provide more information and additional resources. Where you bought your item or a pdf document from an online shop the steps. Not heard anything further about my replacement to Philips Respironics to frequently asked questions have... Disability benefits will not be impacted access the menus on this page perform. Connection withthese recalls and provide more information and additional resources your current status, please log into the or! 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