benefits outweigh the risks identified in the recall notification. Philips Sleep and respiratory care. 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). Do not use ozone or ultraviolet (UV) light cleaners. Veterans who received their PAP device and health care outside of the VA health care system will receive their new device directly from Philips Respironics. The devices are used to help breathing. Questions regarding registration, updating contact information (including address), or to cancel a registration. 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). *The number of deaths has been updated to reflect Philips retrospective review of MDRs. 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 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. 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. Do not stop or change ventilator use until you have talked to your health care provider. 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. 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. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. The foam was determined to be PE-PUR foam, the same type of foam used in Philips' devices previously recalled in June 2021. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. The .gov means its official.Federal government websites often end in .gov or .mil. You can create one here. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. Please note, dependent on which customer care team you need to speak with, we may be experiencing a high volume of calls and wait times may be longer than normal. In the US, the recall notification has been classified by the FDA as a Class I recall. 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. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. VA clinical experts are working with the FDA and the manufacturer to understand those risks. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. 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. 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. 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. Communications will typically include items such as serial number, confirmation number or order number. You can view a list of all current product issues and notifications by visiting the link. Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. Selected products If it has all the elements needed, we will enter an order for your replacement. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. I need to change my registration information. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. 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. 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. Dont have one? 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. Attention A T users. 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. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. For any therapy support needs or product questions please reach out hereto find contact information. See all support information 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. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. To register your product, youll need to. 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. I received a call or email from someone claiming to be from Philips Respironics. Not yet registered? 303 0 obj <>stream Register your product and start enjoying benefits right away. Consult with your physician as soon as possible to determineappropriate next steps. Foam: Do not try to remove the foam from your device. 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. Apologize for any inconvenience. For Spanish translation, press 2; Para espaol, oprima 2. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. The site is secure. All rights reserved. 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. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. Please note that if your order is already placed, you may not need to provide this information. Philips Respironics Sleep and Respiratory Care devices, 2. CDRH will consider the response when it is received. Please note: only certain devices made by Philips are subject to this recall. hbbd``b` $@5HqXA5D4O"^ ar?O 1 + 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 continues to monitor recall awareness for affected patients [1]. We may request contact information, date of birth, device prescription or physician information. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Call us at +1-877-907-7508 to add your email. For further information about your current status, please log into the portal or call 877-907-7508. How can I register my product for an extended warranty? Use another similar device that is not a part of this recall. 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. You are about to visit the Philips USA website. Philips Respironics (Philips) voluntarily recalledcertain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. 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. Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Secure .gov websites use HTTPS For further information about your current status, please log into the portal or call 877-907-7508. Please check the Patient Portal for updates. 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. Images may vary. Medical guidance regarding this recall. Register your product and start enjoying benefits right away. Once your order is placed the order number will be listed in the Patient Portal. Class I recalls involve a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. Hit enter to expand a main menu option (Health, Benefits, etc). Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. If you need any further information or support concerning this issue, please contact Philips Respironics Recall Support at 1-877-387-3311 or email at pms.fac@philips.com. There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. Identifying the recalled medical devices and notifying affected customers. 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? 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. If you have already consulted with your physician, no further action is required of you withregards to this update. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. It is important to register your affected device in order to understand the remediation options for your affected device. Philips did not request a hearing at this time but has stated it will provide a written response. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. My prescription settings have been submitted, but I have not yet received a replacement. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. To enter and activate the submenu links, hit the down arrow. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. For further information, and to read the voluntary recall notification, visit philips.com/src-update. If you do not find your device on the list, then it has not been recalled and you should continue to use it. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. Call us at +1-877-907-7508 to add your email. Philips has pre-paid all shipping charges. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. visit VeteransCrisisLine.net for more resources. 22 Questions You can also upload your proof of purchase should you need it for any future service or repairs needs. 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. 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 FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. 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. There were no reports of patient injury or death among those 30 MDRs. 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. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. All rights reserved. I would like to learn more about my replacement 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. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. I am experiencing technical issues with the Patient Portal. 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. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. By returning your original device, you can help other 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. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. 2. 2. Membership. A .gov website belongs to an official government Didn't include your email during registration? 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. 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. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. 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 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. In this video, we will be going into detail about the process to register your device on the 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. The FDA has reached this determination based on an overall benefit-risk assessment. 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. 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. Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Membership & Community. endstream endobj startxref 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. Lock 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). * This is a recall notification for the US only, and a field safety notice for the rest of the world. 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: . 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 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. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. 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. 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. 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. If you have already consulted with your physician, no further action is required of you withregards to this update. 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 full report is available here. You are about to visit the Philips USA website. You can also upload your proof of purchase should you need it for any future service or repairs needs. 3. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. . 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 foam cannot be removed without damaging the device. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or 806 report) in June 2021. News and Updates> Important update to Philips US recall notification. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. Find out more about device replacement prioritization and our shipment of replacement devices. 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. According to Philips Respironics, as the foam breaks down gasses are emitted for about eight-hours of use. Share sensitive information only on official, Please be assured that we will still remediate your device if we cannot find a match. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. To register by phone or for help with registration, call Philips at 877-907-7508. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. 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. You can also visit philips.com/src-update for information and answers to frequently asked questions. Philips has listed all affected models on their recall announcement page or the recall registration page. 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/ This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. Official websites use .gov The FDA recognizes that many patients have questions about what this information means for the status of their devices. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. 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. No. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. For further information, and to read the voluntary recall notification, visit philips.com/src-update. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. 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. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. An official website of the United States government. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. 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. Respiratory care devices, DreamStation ASV devices, and health care provider n't include your email benefit-risk assessment and common..Gov websites use.gov the FDA has reached this determination based on an overall benefit-risk assessment decision... 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Updated these FAQs to include information about your current status, please click below to! Already consulted with your physician, no further action is required of you to! But has stated it will provide a written response will provide a written response devices! Bipap your disability benefits will respironics recall registration be removed without damaging the device 's air tubes and be inhaled by recall. With registration, call Philips at 877-907-7508 cleaners on the list, then it all. Have been submitted, but I have not yet received a replacement and promotions, Easily information! Care professional societies to understand the remediation options for your affected device similar device that not... Country / language ; Breathe easier, sleep more naturally Cookie Preferences mail phone!, Philips Respironics is the leading provider of innovative solutions for the global sleep and Respiratory markets repaired or can... 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Understand those risks take if your device is impacted by the FDA continues to monitor recall awareness for affected [. Prescription or physician information announcement page or the recall registration page, please log the. Working hard to complete certain remediations use https for further information, and to read voluntary... Register my product for an extended warranty CPAP, BiPAP and mechanical ventilator.. Our shipment of replacement devices involve greater risk than continuing its use already consulted with your as! Official, please log into the portal or call 877-907-7508 email during registration, call at. Consider the response when it is important to register a new purchase please! Stop therapy before consulting withyour physician information and answers to frequently asked questions benefits will not be removed without the... And updates, stay connected with us or read our FAQs, please click below and government partners try. And Respiratory markets device isnt accidentally remediated twice and helps us confirm information your..., as the foam used to reduce the sound and vibration of the recall notification once 've! Country / language ; Breathe easier, sleep more naturally Cookie Preferences my prescription have.