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: RecallPrescriptions@philips.com PAP Recall Guidance 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. We are investigating potential injury risks to users, including several cancers. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. Register your product and start enjoying benefits right away. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. Although MDRs are a valuable source of information, this passive surveillance system has limitations. Call us at +1-877-907-7508 to add your email. 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. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Philips recalled the following devices made between 2009 and April 26, 2021: Philips also recalled certain Trilogy Evo ventilators distributed from April 15, 2021 to May 24, 2021 with specific serial numbers. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). 303 0 obj <>stream Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. The FDA's evaluation of the information provided by Philips is ongoing. secure websites. Register your product and start enjoying benefits right away. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. To register your product, youll need to log in to your My Philips account. Be aware that during the 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 certain chemicals of concern, called volatile organic compounds (VOCs). If you receive your sleep care from VA, contact your respiratory case manager and provide them with your serial number. 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. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. All rights reserved. Can we help? 1. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. 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. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. Membership & Community. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. The incidence, prevalence, or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about details such as frequency of device use. If you have completed this questionnaire previously, there is no need to repeat your submission. 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. 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. You can also visit philips.com/src-update for information and answers to frequently asked questions. 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. Philips Sleep and respiratory care. Philips has not yet provided the FDA with all information we requested to evaluate the risks from the chemicals released from the foam, though they have posted Clinical information for physicians on their website. Determining the number of devices in use and in distribution. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. 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. The website provides you current information on the status of the recall and how to receive permanent corrective action to address the two (2) issues. 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. 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. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. At this time, the FDA does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S. Continue to use your repaired or replaced device. 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. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. 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. Is there a question we can answer for you? Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to . The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. organization in the United States. I am experiencing technical issues with the Patient Portal. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. I received a call or email from someone claiming to be from Philips Respironics. Philips Respironics continues to monitor recall awareness for affected patients [1]. Cleaning, setup and return instructions can be found here. A locked padlock In the US, the recall notification has been classified by the FDA as a Class I recall. No. Create account Create an account Already have an account? The full report is available here. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. If youre interested in providing additional information for the patient prioritization, check your order status. The site is secure. The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or 806 report) in June 2021. We recommend you upload your proof of purchase, so you always have it in case you need it. You are about to visit a Philips global content page. Secure .gov websites use HTTPS 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. The FDA has worked with patients and health care professional organizations, including the American Sleep Apnea Association, the COPD (chronic obstructive pulmonary disease) Foundation, the Muscular Dystrophy Association, the Mended Hearts, Inc., American College of Chest Physicians, American Thoracic Society, and the American Academy of Sleep Medicine, and has included this feedback in these FAQs. 2. Philips has listed all affected models on their recall announcement page or the recall registration page. In the US, the recall notification has been classified by the FDA as a Class I recall. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Only clean your device according to the manufacturers recommendations. . *The number of deaths has been updated to reflect Philips retrospective review of MDRs. Philips Respironics created an online registration process to allow patients to look up their device serial number . 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. 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 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. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . 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. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. For patients using life-sustaining ventilation, continue prescribed therapy. A .gov website belongs to an official government How can I register my product for an extended warranty? How can I tell if a recent call, letter or email is really from Philips Respironics? CHEST MEMBERSHIP About Membership . The foam was determined to be PE-PUR foam, the same type of foam used in Philips' devices previously recalled in June 2021. 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. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. 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. Matching your registration to your Durable Medical Equipment provider (DME), Find out if your device is matched to a DME registration, Your device registration is matched to your DME, Please contact the Philips Customer Service team directly on. 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. Find out more about device replacement prioritization and our shipment of replacement devices. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. For further information about your current status, please log into the portal or call 877-907-7508. Repairing and replacing the recalled devices. Please note: only certain devices made by Philips are subject to this recall. I have general DreamMapper questions or DreamMapper connection issues. You are about to visit a Philips global content page. Your replacement will come with a box to return your current device to Philips Respironics. Before sharing sensitive information, make sure you're on a federal government site. Home | Philips Recall (expertinquiry.com), Philips Frequently Asked Questions (FAQ) Web Version, Philips Frequently Asked Questions (FAQ) PDF Version, FDA: Philips Respironics CPAP Machine Recall Announcement. To register your product, youll need to log in to your My Philips account. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. If you use a Philips Respironics CPAP or BiPAP device that is included in the recall, continue using your device as prescribed until a new device is available. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. I would like to learn more about my replacement device. You can create one here. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Lifestyle Measures to Manage Sleep Apnea fact sheet. How can I tell if a recent call, letter or email is really from Philips Respironics? Use another similar device that is not a part of this recall. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain. 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. You can log in or create one here. 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. 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. Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and mechanical Ventilator Devices due to issues related to deterioration of the sound abatement foam used in these devices. 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. 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. Access all your product information in one place (orders, subscriptions, etc. We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. 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. 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. Dont have one? 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. For further information about your current status, please log in to the. Communications will typically include items such as serial number, confirmation number or order number. 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. 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. I have received my replacement device and have questions about setup and/or usage. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. Philips has pre-paid all shipping charges. 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? The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. If you are in crisis or having thoughts of suicide, The returned affected device will be repaired for another patient that is waiting within the replacement process. Koninklijke Philips N.V., 2004 - 2023. Official websites use .gov With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) 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. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. You are about to visit a Philips global content page. It may also lead to more foam or chemicals entering the air tubing of the device. What information do I need to provide to register a product? It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. First, determine if you are using one of the affected devices. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. 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. If you have already consulted with your physician, no further action is required of you withregards to this update. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. On June 14, 2021, Philips Respironics sent customers an "Urgent: Medical Device Recall" letter requesting them to take the following actions: Discontinue use of the device and work with a. 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. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Be cautious as they may be scams! You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. CHEST Issues Joint Statement in Response to Philips Device Recall . The FDA has reached this determination based on an overall benefit-risk assessment. The returned affected device will be repaired for another patient that is waiting within the replacement process. 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. To register by phone or for help with registration, call Philips at 877-907-7508. Philips Respironics has issued a . 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. There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. Creating a plan to repair or replace recalled devices. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. If we cannot find a match, we may reach out to you for additional information. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. No. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Overview. For further information, and to read the voluntary recall notification, visit philips.com/src-update. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, Recalled BiPAP or CPAP Machines & Recommendations, Repaired and Replaced BiPAP or CPAP Machines & Recommendations, Potential Health Risks from the PE-PUR Foam, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Register your device(s) on Philips' recall website, report the issue or problem through the MedWatch Voluntary Reporting Form, problem through the MedWatch Voluntary Reporting Form, potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories, report the problem through the MedWatch Voluntary Reporting Form, FDA's user facility reporting requirements, Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Garbin Plus, Aeris, LifeVent (ventilator). 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