You can create one here. You can also visit philips.com/src-update for information and answers to frequently asked questions. In April 2021, Philips first notified the FDA of their intention to conduct a field action due to concerns pertaining to foam breakdown in certain ventilators, BiPAP machines, and CPAP machines. Veterans Crisis Line: To date there have been no reports of death from exposure to the recalled devices. On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. Philips Respironics Sleep and Respiratory Care devices, 2. 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. 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 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. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. If you have been informed that you can extend your warranty, first you need a My Philips account. If we cannot find a match, we may reach out to you for additional information. Be cautious as they may be scams! I have general DreamMapper questions or DreamMapper connection issues. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. 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. 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. Our Prescription Team is required to review all prescriptions. CHEST MEMBERSHIP About Membership . If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Membership. The potential health risks from the foam are described in the FDA's safety communication. 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. 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. 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. 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. Register your product and start enjoying benefits right away. For further information about your current status, please log in to the. The data collected will be used to help to prioritize remediation of those patients at higher risk. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. Continuous Positive Airway Pressure (CPAP) devices, Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and, Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to register their device). 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. have hearing loss. Philips Respironics continues to monitor recall awareness for affected patients [1]. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. 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 FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Images may vary. No. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. Following two rounds of comprehensive customer and patient outreach, Philips Respironics has reached the vast majority of the installed base in the US resulting in the registration of approximately 2.6 million devices in the country. CHEST Issues Joint Statement in Response to Philips Device Recall . Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. If youre interested in providing additional information for the patient prioritization, check your order status. There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. 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. Please be assured that we will still remediate your device if we cannot find a match. For more information of the potential health risks identified, see the FDA Safety Communication. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. This will come with a box to return your current device to Philips Respironics. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. 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. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. 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. Hit enter to expand a main menu option (Health, Benefits, etc). You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. The FDA's evaluation of the information provided by Philips is ongoing. 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. What information do I need to provide to register a product? 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 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. 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. . Log in For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. The full report is available here. The returned affected device will be repaired for another patient that is waiting within the replacement process. How can I tell if a recent call, letter or email is really from Philips Respironics? Your replacement device will include three key pieces of information, including how-to: Set up your device Clean and assemble existing components Return instructions. b. Breathing in chemicals or swallowing small pieces of foam that has broken apart could potentially result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury. When the PE-PUR foam breaks down, it may: The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include: The potential risks of inhaling chemicals released into the device's air tubes from the PE-PUR foam include: During the 2021 manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of VOCs. The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. 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. To register a new purchase, please have the product on hand and log into your My Philips account. Well reach out via phone or email with questions and you can always check your order status online. More information on. We recommend you upload your proof of purchase, so you always have it in case you need it. Very small particles from the foam could break lose and come through the air hose. There are no updates to this guidance. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. 2. Creating a plan to repair or replace recalled devices. Philips Sleep and respiratory care. Cleaning, setup and return instructions can be found here. visit VeteransCrisisLine.net for more resources. 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. Please note that if your order is already placed, you may not need to provide this information. Philips Respironics issued a statement on September 1, 2021 informing United States-based customers of its new repair and replacement program for first-generation DreamStation devices in relation to the June 14, 2021 recall notification.The vast majority of the registered affected devicesmore than 80%are from the first-generation DreamStation product family, and more than half of the . Please check the Patient Portal for updates. There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. That will allow them place an order for your supplies. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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 You can still register your device on DreamMapper to view your therapy data. We are actively working to match patient registration serial numbers with DMEs that sold the device. 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. If you receive your sleep care from VA, contact your respiratory case manager and provide them with your serial number. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Philips has listed all affected models on their recall announcement page or the recall registration page . 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. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. 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. For further information about your current status, please log in to the Patient Portal or call 877-907-7508. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). If you do not find your device on the list, then it has not been recalled and you should continue to use it. Then you can register your product. 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. * This is a recall notification for the US only, and a field safety notice for the rest of the world. You are about to visit the Philips USA website. Philips has listed all affected models on their recall announcement page or the recall registration page. You can log in or create one here. 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. 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. You are about to visit the Philips USA website. Before sharing sensitive information, make sure you're on a federal government site. 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. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. Communications will typically include items such as serial number, confirmation number or order number. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. 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. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. Membership & Community. 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. Trying to or successfully removing the foam may damage the device or change how the device works. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. There are no updates to this guidance. In the US, the recall notification has been classified by the FDA as a Class I 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. 3. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. 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. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. 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Plan to repair or replace recalled devices phone or email with questions and you continue. General DreamMapper questions or DreamMapper connection issues recall awareness for affected patients [ 1 ] on 14. Or successfully removing the foam could break lose and come through the device works document from an shop! Assured that we will reach out to you for clarification check your status! How can I tell if a recent call, letter or email with and!
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