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. 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. Koninklijke Philips N.V., 2004 - 2023. Veterans Crisis Line: 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. benefits outweigh the risks identified in the recall notification. By returning your original device, you can help other patients. a. More information on. The DME supplier can check to see if your device has been recalled. 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. Attention A T users. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. Create account Create an account Already have an account? See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. 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. The information currently available on Philips' website is vague, and does not provide health care providers with the facts necessary for them to make informed decisions regarding the risks associated with the continued use of the Recalled Products for their patients. There are no updates to this guidance. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. 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). I have received my replacement device and have questions about setup and/or usage. 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. CHEST Issues Joint Statement in Response to Philips Device Recall . 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. 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. 303 0 obj <>stream If you have already consulted with your physician, no further action is required of you withregards to this update. Official websites use .gov Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. The .gov means its official.Federal government websites often end in .gov or .mil. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. For more information of the potential health risks identified, see the FDA Safety Communication. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. Dont have one? I have general DreamMapper questions or DreamMapper connection issues. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. 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. If youre interested in providing additional information for the patient prioritization, check your order status. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. Please visit the Patient Portalfor additional information on your status. First, determine if you are using one of the affected devices. You are about to visit the Philips USA website. 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. 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. Creating a plan to repair or replace recalled devices. Contact and support for Philips Respironics voluntary recall Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. 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 . Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. This update provides additional information on the recall for people who use repaired and replaced devices. Koninklijke Philips N.V., 2004 - 2023. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. The site is secure. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Please note: only certain devices made by Philips are subject to this recall. Call us at +1-877-907-7508 to add your email. If you have a health issue and are using or have used a recalled or replaced device or have any problem with your device, talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. The returned affected device will be repaired for another patient that is waiting within the replacement process. organization in the United States. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. 272 0 obj <> endobj 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. secure websites. 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. 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. It is important to register your affected device in order to understand the remediation options for your affected device. Share sensitive information only on official, Your replacement device will include three key pieces of information, including how-to: Set up your device Clean and assemble existing components Return instructions. 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. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. 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. 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. 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. To access the menus on this page please perform the following steps. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. 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. You can still register your device on DreamMapper to view your therapy data. 1. Apologize for any inconvenience. 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. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. 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 Do not use ozone or ultraviolet (UV) light cleaners. %%EOF Why do I need to upload a proof of purchase? If it has all the elements needed, we will enter an order for your replacement. Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices 3,950,000 repair kits and replacement devices produced to date globally 2,000,000 devices shipped in the US For further information about your current status, please log in to the. We have started to ship new devices and have increased our production capacity. 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. The FDA recognizes that many patients have questions about what this information means for the status of their devices. 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. To register your product, youll need to. 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? Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. 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. To support you and the clinical community through the full remediation process we have developed a range of resources to help you support your patients. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. Keep your registration confirmation number. 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. Call us at +1-877-907-7508 to add your email. For patients using life-sustaining ventilation, continue prescribed therapy. 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. You are about to visit the Philips USA website. You can also visit philips.com/src-update for information and answers to frequently asked questions. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. Membership & Community. 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. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. Before sharing sensitive information, make sure you're on a federal government site. There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. 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. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. 1. You are about to visit a Philips global content page. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. CDRH will consider the response when it is received. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. endstream endobj startxref We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. At this time no serious adverse health events have been reported but Philips Respironics has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. The data collected will be used to help to prioritize remediation of those patients at higher risk. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. endstream endobj 273 0 obj <>/Metadata 11 0 R/Pages 270 0 R/StructTreeRoot 18 0 R/Type/Catalog/ViewerPreferences 288 0 R>> endobj 274 0 obj <>/MediaBox[0 0 612 792]/Parent 270 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 275 0 obj <>stream This will allow all end users to make informed decisions regarding the risks of continued use of the Recalled Products while awaiting a replacement device. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. It may also lead to more foam or chemicals entering the air tubing of the device. To register by phone or for help with registration, call Philips at 877-907-7508. 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. 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). c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Is there a question we can answer for you? Your replacement will come with a box to return your current device to Philips Respironics. 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. 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. Trying to or successfully removing the foam may damage the device or change how the device works. 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. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. CHEST MEMBERSHIP About Membership . 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. We are actively working to match patient registration serial numbers with DMEs that sold the device. We may request contact information, date of birth, device prescription or physician information. Once your order is placed the order number will be listed in the Patient Portal. We recommend you upload your proof of purchase, so you always have it in case you need it. 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. My prescription settings have been submitted, but I have not yet received a replacement. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. We may need more information from you or you may have other options available to you, including alternative replacement devices or financial payment, dependent on your specific situation. 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. 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