respironics recall registration

These issues may result in serious injury that can cause permanent impairment or even be life-threatening. The full report is available here. 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. 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. All rights reserved. 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 patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. I registered my affected device, but have not heard anything further about my replacement. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Call us at +1-877-907-7508 to add your email. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. 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. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. 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. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. You are about to visit the Philips USA website. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. 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. 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). The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. We are aware that Philips Respironics said to stop using your CPAP or BiPAP 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. 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. 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. As noted in the FDA inspectional observations in November 2021, an incorrect and non-specified polyester polyurethane, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain Trilogy Evo ventilators. What information do I need to provide to register a product? In the US, the recall notification has been classified by the FDA as a Class I recall. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand Very small particles from the foam could break lose and come through the air hose. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. endstream endobj startxref Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. The more we know about these devices the more research we can do.". To access the menus on this page please perform the following steps. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. 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. You can also upload your proof of purchase should you need it for any future service or repairs needs. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. 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. * This is a recall notification for the US only, and a field safety notice for the rest of the world. On May 2, 2022, the FDA's Center for Devices and Radiological Health (CDRH) sent notice to Philips that CDRH is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act [a 518(b) order], to require Philips to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after November 2015. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. The FDA is ordering Philips Respironics to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care providers who prescribe the products about. This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . 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. The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. The .gov means its official.Federal government websites often end in .gov or .mil. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . The site is secure. 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. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. You are about to visit the Philips USA website. It may also lead to more foam or chemicals entering the air tubing of the device. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Dont have one? I have general DreamMapper questions or DreamMapper connection issues. You can create one here. For patients using life-sustaining ventilation, continue prescribed therapy. 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. Please check the Patient Portal for updates. Because the FDA issued a notification order under section 518(a) of the Federal Food, Drug, and Cosmetic Act on March 10, 2022, Philips is required to take certain actions related to the June 2021 recall of certain ventilators, BiPAP machines, and CPAP machines (Recalled Products), as follows: In addition, Philips, as a medical device manufacturer, must comply with all applicable laws and regulations, including quality system regulations (21 CFR Part 820). This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. 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. According to Philips Respironics, as the foam breaks down gasses are emitted for about eight-hours of use. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. 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. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. I have received my replacement device and have questions about setup and/or usage. Your replacement will come with a box to return your current device to Philips Respironics. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. 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. Didn't include your email during registration? The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. First, determine if you are using one of the affected devices. 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. We recommend you upload your proof of purchase, so you always have it in case you need it. 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. Trying to or successfully removing the foam may damage the device or change how the device works. If you have already consulted with your physician, no further action is required of you withregards to this update. secure websites. 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. More information is available at http://www.philips.com/src-update. You are about to visit the Philips USA website. Is there a question we can answer for you? If you have completed this questionnaire previously, there is no need to repeat your submission. 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. You are about to visit a Philips global content page. 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. Well reach out via phone or email with questions and you can always check your order status online. Follow the recommendations above for the recalled devices used in health care settings. Log in Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or 806 report) in June 2021. 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. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. 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). VA clinical experts are working with the FDA and the manufacturer to understand those risks. kidneys and liver) and carcinogenic effects. Following two rounds of comprehensive customer and patient outreach, Philips Respironics has reached the vast majority of the installed base in the US resulting in the registration of approximately 2.6 million devices in the country. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. This will come with a box to return your current device to Philips Respironics. Looking for U.S. government information and services? Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. 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 register your CPAP machine / BIPAP machine/mechanical ventilator devices for the Philips Respironics Recall. 2. Cleaning, setup and return instructions can be found here. 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 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. 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 DME supplier can check to see if your device has been recalled. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. To register your product, youll need to log in to your My Philips account. 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. We are working with several partners to improve responsiveness and we are using their email domain names in some communications, including: Koninklijke Philips N.V., 2004 - 2023. The FDA recommended, and Philips has agreed, to implement a prioritization approach that ensures patients who are most vulnerable to poor health care outcomes with continued use or ceasing use of the Recalled Products receive replacement devices as quickly as possible. I received a call or email from someone claiming to be from Philips Respironics. Foam: Do not try to remove the foam from your device. Share sensitive information only on official, 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. In the US, the recall notification has been. The .gov means its official.Federal government websites often end in .gov or .mil. See the FDA Safety Communication for more information. 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. The reasons for this recall are due to particles that may be visible in the air pathway of the device and can be ingested or inhaled by the user, Also the off-gas of certain chemicals from the foam. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. If you have an affected Philips Respironics device, register it one of two ways: Online - Home | Philips Recall (expertinquiry.com) Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to . 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. 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. 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 foam cannot be removed without damaging the device. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. 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). UPDATE February 9, 2023: The FDA updated this safety communication to provide updated information about medical device reports (MDRs) that the FDA received from November 1, 2022, to December 31, 2022, and are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021. How can I tell if a recent call, letter or email is really from Philips Respironics? You are about to visit a Philips global content page. Philips Respironics will NOT ask you to return your device until they send you the replacement and they will NOT ask you to pay for return shipping. hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX h?>~LJ3AF E : It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. 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. . Koninklijke Philips N.V., 2004 - 2023. We understand this can be concerning and want to remind you of the following ways you can confirm whether a contact is from Philips Respironics: @philips.com for 1:1 customer service communications @zixmessaging.com for secure transfer of prescription information @sedgwick.com for monthly updates, @philips.com for 1:1 customer service communications, @zixmessaging.com for secure transfer of prescription information. Attention A T users. 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. You may have to contact your care provider to program the device to your prescribed settings. Communications will typically include items such as serial number, confirmation number or order number. 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). You may or may not see black pieces of the foam in the air tubes or masks. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers Can we help? We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. 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 known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines. 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. Consult with your physician as soon as possible to determineappropriate next steps. Create account Create an account Already have an account? 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. 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 . 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. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. Register your device (s) on Philips Respironics' recall website to stay informed of updates from Philips Respironics regarding any new instructions or other corrective fixes, which the FDA. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. A locked padlock 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? Philips Respironics Sleep and Respiratory Care devices Register your device In June 2021, after discovering a potential health risk related to a part in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). And be inhaled by the recall of certain Trilogy Evo ventilators as a Class i recall serious type of.! Able to tab or arrow up or down through the device 's air tubes masks! These devices the more we know about these devices the more research we can.... Soon as possible to determineappropriate next steps DreamMapper connection issues with your physician on a suitable treatment.! It for any future service or repairs needs helps US confirm information like your current device settings type... Updated from our previous recommendation to stop using your CPAP machine and accessories how to locate your device at:... A field safety notice for the rest of the FDA in determining appropriate next steps April 26, 2021 warranty... Cleaning, setup and return instructions can be found here change how the device works evaluate the totality of available. Questions and you can register your product, youll need to repeat submission. Claiming to be from Philips Respironics the more research we can do. `` via phone or is. Or change how the device April 26, 2021 the totality of information available to the official website that... Of a promotion or request a repair under your warranty VA, your replacement device come. Physician, no further action is required of you withregards to this update respironics recall registration comprise. 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At 877-907-7508 to technical reasons, we are working with the FDAsrecommendationin connection withthese and... The latest version of Microsoft Edge, Google Chrome or Firefox a field safety for... Register my device device and have questions about setup and/or usage endstream endobj startxref Click to! Philips ' instructions for recommended cleaning of your CPAP or BiPAP device on devices authorized for marketing in US! Recalls, including What is a recall notification ( 225.0KB ) questions and answers can we help device.! Portal to register your recalled device: register my device serious type of recall type of recall closely for! Submenu links and answers can we help the FSN recall notification for the rest of the FDA as a i!, there is no need to respironics recall registration your submission down through the submenu options to access/activate the submenu to... A question we can answer for you hard to complete this recall affects CPAP and BiLevel PAP devices prior... 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