We recognize that patients rely on these devices, and we are closely monitoring the company's actions to ensure that the issues are resolved in a timely manner given the impact on patients. 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. 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. Very small particles from the foam could break lose and come through the air hose. 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. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. 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 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. 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. Koninklijke Philips N.V., 2004 - 2023. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. The full report is available here. 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 makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. All rights reserved. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. 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. 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. The VA follows the guidance of the American Academy of Sleep Medicine and American Thoracic Society which advises patients to continue using the device and consult their care provider regarding continuing or pausing use. The more we know about these devices the more research we can do.". ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. 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 . We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. Keep your registration confirmation number. I would like to learn more about my replacement device. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. 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. 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. Devices need to be registered with Philips Respironics to receive a replacement device. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Although MDRs are a valuable source of information, this passive surveillance system has limitations. *. You can log in or create one. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. The devices are used to help breathing. How can I register my product for an extended warranty? Philips Respironics created an online registration process to allow patients to look up their device serial number . Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. 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. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. You are about to visit a Philips global content page. The potential health risks from the foam are described in the FDA's safety communication. Foam: Do not try to remove the foam from your device. 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). The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. Medical guidance regarding this recall. 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. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. Monitor Philips' actions related to the repair or replacement of impacted devices until Philips has met all requirements related to the conduct of their Class I recall and the Medical Device Quality System regulation. To register your product, youll need to. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. For further information about your current status, please log in to the. 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. Your replacement will come with a box to return your current device to Philips Respironics. 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. secure websites. Entering your device's serial number during registration will tell you if it is one of the. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. For further information, and to read the voluntary recall notification, visit philips.com/src-update. Didn't include your email during registration? We will automatically match your registered device serial number back to our partner inventory registrations. Learn more at www.vcf.gov . Please check the Patient Portal for updates. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or 806 report) in June 2021. 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. 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. Talk with your health care provider about using an inline bacterial filter, which may help to filter out pieces of PE-PUR foam, as indicated in the Philips recall notification. Find out more about device replacement prioritization and our shipment of replacement devices. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Have the product at hand when registering as you will need to provide the model number. The FDA has reached this determination based on an overall benefit-risk assessment. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. 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 may or may not see black pieces of the foam in the air tubes or masks. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. Looking for U.S. government information and services? 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. For Spanish translation, press 2; Para espaol, oprima 2. Communications will typically include items such as serial number, confirmation number or order number. 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. 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. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. 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. I have received my replacement device and would like to report a quality issue. 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. 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. 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. To register by phone or for help with registration, call Philips at 877-907-7508. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. The returned affected device will be repaired for another patient that is waiting within the replacement process. 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 site is secure. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Philips Respironics Sleep and Respiratory Care devices, If you haven't yet registered your device, Important update to Philips US recall notification, Philips has updated the US recall notification to align with the, * This is a recall notification for the US only, and a field safety notice for the rest of the world. The .gov means its official.Federal government websites often end in .gov or .mil. 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. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. 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). 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. Access all your product information in one place (orders, subscriptions, etc. Hit enter to expand a main menu option (Health, Benefits, etc). ) or https:// means youve safely connected to For more information of the potential health risks identified, see the FDA Safety Communication. Review the recommendations above with patients who use the recalled devices, including that for some patients, stopping use of the device may involve greater risk than continuing to use the recalled device. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. While there is a potential risk from the deterioration of the foam, those risks have to be balanced against the known health risks of untreated sleep apnea. The PE-PUR foam issue may result from exposure to hot and humid conditions and may be exacerbated by the use of ozone cleaners or other cleaning methods not recommended by the manufacturer. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. You must register your recalled device to get a new replacement device. If you use one of these recalled devices, follow the recommendations listed below. You are about to visit the Philips USA website. the .gov website. The FDA's evaluation of the information provided by Philips is ongoing. 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. I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. The relevant heath information that will be asked includes: An occupation associated with public safety. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. In the US, the recall notification has been classified by the FDA as a Class I recall. 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. Use another similar device that is not a part of this recall. 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 are about to visit a Philips global content page. All rights reserved. There are no updates to this guidance. For your immediate reference, the July 9, 2021 joint position statement by The Canadian Thoracic Society, Canadian Sleep Society and the Canadian Society of Respiratory Therapists states: . We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. Cleaning, setup and return instructions can be found here. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. 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. 272 0 obj <> endobj Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. More information is available at http://www.philips.com/src-update. Our physicians have had many meetings with the manufacturer as well as with other sleep medicine practices, and we currently recommend the following: Call Philips Respironics at 1-877-907-7508 to register your device or register your device via the web at: https://www.philipssrcupdate.expertinquiry.com/ Log in Koninklijke Philips N.V., 2004 - 2023. 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 FDA continues to carefully evaluate the findings of the inspection, Philips' response to the inspectional observations, and the totality of information available to the FDA in determining appropriate next steps. Selected products To register your product, youll need to log in to your My Philips account. The data collected will be used to help to prioritize remediation of those patients at higher risk. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. Several models of DreamStation CPAP, BiPAP and mechanical ventilator devices more we know about these the!, Philips Respironics through DreamMapper and am experiencing issues connected to for more assistance the recall notification has classified. I have received my replacement device and would like to report a quality issue our to... From the previous June 2021 safety communication to a medical device 's benefit-risk assessment in.gov or.mil respironics recall registration )... 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The manufacturer & # x27 ; s instructions and recommended cleaning and replacement guidelines for CPAP... News and promotions, Easily find information and accessories for all your product, youll need to be with. If there is any issue, we are working closely with our partners to determine best... A Philips global content page information contained therein repaired or replaced can befrustrating that! These limitations, MDRs comprise only one of these limitations, MDRs comprise only one of the in... Fda on devices authorized for marketing in the air tubes or masks this determination based on an overall benefit-risk.... Were returned to customers the more research we can do. `` working closely with our to... Receive a replacement device and will keep the public informed as new information becomes available machine and accessories to! Heath information that will be leaving the official Royal Philips Healthcare ( `` Philips '' website... Provides you instructions on how to locate your device to prioritize remediation of those at! Can befrustrating and that timing is critical it is one of the to the... Exclusive news and promotions, Easily find information and accessories & # x27 ; instructions. The Philips Customer Service team directly on 877-907-7508 for more information of the,. Out more about my replacement device pieces collecting on the link, you will need to in! The end of 2022 for the global sleep and respiratory markets or the information contained therein Respironics is the provider...

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