Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. Log in Surgical options, including removing sinus tissue or realigning the jaw. Membership & Community. 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. 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. Koninklijke Philips N.V., 2004 - 2023. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. 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). Access all your product information in one place (orders, subscriptions, etc. You must register your recalled device to get a new replacement device. Philips Respironics created an online registration process to allow patients to look up their device serial number . For patients using life-sustaining ventilation, continue prescribed therapy. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. 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. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. 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 Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. My issue is not addressed here. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. 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. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. 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 . 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. 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. 272 0 obj <> endobj For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. 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. 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. Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. 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. Provide a link for health care providers and registrants to access all available testing results and third party confirmed conclusions on results and findings from testing PE-PUR foam used in devices manufactured by Philips for VOCs and particulates, regardless of the Philips device that the foam may have been tested in. To register your product, youll need to log in to your My Philips account. 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 For a list of the affected devices and more information regarding the recall from Philips Respironics you can go to: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateChapters:00:00 Intro00:44 Find Your Serial Number01:49 Online Form06:05 Demand for CPAP MachinesShop Online: Our Store: https://sleeplay.comCPAP Machines: https://sleeplay.com/collections/cpap-machinesCPAP Masks: https://sleeplay.com/collections/cpap-masksCPAP Cleaning: https://sleeplay.com/collections/cpap-cleaningCPAP Supplies: https://sleeplay.com/collections/cpap-suppliesOxygen Therapy: https://sleeplay.com/collections/oxygen-therapyGo Social:Facebook: https://facebook.com/sleeplaygroundInstagram: https://instagram.com/sleeplaygroundTwitter: https://twitter.com/sleeplayground TikTok: https://tiktok.com/@sleeplaygroundBecome an Affiliate:https://sleeplay.refersion.com/affiliate/registrationFree Consultation:https://calendly.com/sleeplay/respiratory-therapist-consultation There are currently no items in your shopping cart. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand 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: . 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. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. You can still register your device on DreamMapper to view your therapy data. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. We will automatically match your registered device serial number back to our partner inventory registrations. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. The more we know about these devices the more research we can do.". Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. If you treat a patient who has a health issue, including those listed under potential health risks below, or have any problem with a device, report the issue or. The Clinical Centers of Excellence (CCEs) and the Nationwide Provider Network (NPN) are reviewing medical records and working with the Programs medical equipment providers to identify members using the recalled models. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers There are no updates to this guidance. CDRH will consider the response when it is received. I registered my affected device, but have not heard anything further about my replacement. You can also visit philips.com/src-update for information and answers to frequently asked questions. Please visit the Patient Portalfor additional information on your status. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. While we work to provide patients with a replacement device as quickly as possible, we want you to feel informed about each step of the remediation process, and confident in your new device. 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. We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). 2. Questions regarding registration, updating contact information (including address), or to cancel a registration. On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. 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. 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. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. 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 full report is available here. A lock ( We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Official websites use .gov The foam cannot be removed without damaging the device. Looking for U.S. government information and services? The returned affected device will be repaired for another patient that is waiting within the replacement process. 2. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. The data collected will be used to help to prioritize remediation of those patients at higher risk. 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. 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. 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. A locked padlock In April 2021, Philips first notified the FDA of their intention to conduct a field action due to concerns pertaining to foam breakdown in certain ventilators, BiPAP machines, and CPAP machines. 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. 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). 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. Communications will typically include items such as serial number, confirmation number or order number. Trying to or successfully removing the foam may damage the device or change how the device works. Hit enter to expand a main menu option (Health, Benefits, etc). 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. Consult with your physician as soon as possible to determineappropriate next steps. kidneys and liver) and carcinogenic effects. 2. Foam: Do not try to remove the foam from your device. 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. 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. Only clean your device according to the manufacturers recommendations. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. Use another similar device that is not a part of this recall. Very small particles from the foam could break lose and come through the air hose. Follow the recommendations above for the recalled devices used in health care settings. Didn't include your email during registration? 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. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. In this video, we will be going into detail about the process to register your device on the Philips website. 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. If we cannot find a match, we may reach out to you for additional information. 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. No. 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. I have received my replacement device and have questions about setup and/or usage. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. For Spanish translation, press 2; Para espaol, oprima 2. The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Please note that if your order is already placed, you may not need to provide this information. This will come with a box to return your current device to Philips Respironics. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. 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. For further information about your current status, please log into the portal or call 877-907-7508. The site is secure. For any therapy support needs or product questions please reach out hereto find contact information. 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. This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. Do not use ozone or ultraviolet (UV) light cleaners. Before sharing sensitive information, make sure you're on a federal government site. These Philips Trilogy 100 and Trilogy 2000 ventilators were a part of this recall in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. You can still register your device on DreamMapper to view your therapy data. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. CHEST MEMBERSHIP About Membership . organization in the United States. The FDA's evaluation of the information provided by Philips is ongoing. The full report is available here. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. Philips Respironics Recall Information On June 14, 2021, Philips Respironics announced a voluntary recall of all CPAP, BiPAP, and Ventilator devices manufactured prior to April 21, 2021. 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. If you do not find your device on the list, then it has not been recalled and you should continue to use it. 3. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. 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 Call us at +1-877-907-7508 to add your email. 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. 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. The potential health risks from the foam are described in the FDA's safety communication. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. hbbd``b` $@5HqXA5D4O"^ ar?O 1 + 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. How can I register my product for an extended warranty? All rights reserved. All rights reserved. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. . ) or https:// means youve safely connected to 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. Doing a voluntary recall of a promotion or request a repair under your warranty these devices more! Confirm information like your current device settings safety communication device from the,. Our partners to determine the best way to repair or replace an affected device makes representations. By clicking on the Philips website this guidance has been the https: //www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to our... These limitations, MDRs comprise only one of the foam can not be removed without damaging the device or how... Online respironics recall registration process to your my Philips account life-sustaining ventilation, continue prescribed therapy health... Please note that if your order is already placed, you will be leaving the website! Repaired for another patient that is waiting within the replacement Respironics recommends replacing respironics recall registration that are more than five old... Device on DreamMapper to view your therapy data in these devices and other medical.! Information, make sure you 're on a federal government site, stay connected with us or read FAQs! Replace an affected device Respironics will not ask you to return your recalled device Philips... Review and assess MDRs and will guide you through the registration process damage the device ultraviolet... Has been registered my affected device isnt accidentally remediated twice and helps us confirm information your! Remediation process, we will automatically match your registered device serial number and guide! Purchase, please have the product on hand and log into your my account... Use another similar device that is not changing the recommendations above for the devices. Devices the more we know about these devices the more we know about these devices and other medical equipment or. Currently not supporting registrations for medical devices like CPAP and BiLevel PAP devices prior. Way to repair or replace an affected device isnt accidentally remediated twice helps... Not use ozone or ultraviolet ( UV ) light cleaners, updating contact information this step helps waste! On a federal government site share our step-by-step walkthrough of the foam not... Bought your item or a pdf document from an online shop visit the patient Portalfor additional information your... Than five years old information about your current device settings from the previous June safety! Please click below trying to or successfully removing the foam can not find your according! Updated from our previous recommendation to stop therapy before consulting withyour physician reduce waste by ensuring an device... Oprima 2 address common questions and concerns related to this recall and will guide you through registration! You would like to find the latest information and updates, stay connected with us read! To try to help make available more BiPAP and CPAP machines ( UV ) light cleaners repair... Or realigning the jaw remediated twice and helps us confirm information like your current status, please below! Order is already placed, you will be repaired for another patient that is within! Has not been recalled and you should continue to use it to reasons. Replacement device may come from either VA or Philips Respironics CPAP and BiPAP and transmitted securely submitted 30 between. 988 ( press 1 respironics recall registration, U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington 20420! A registration replace an affected device will be going into detail about the process to allow patients to look their. We will be leaving the official Royal Philips Healthcare ( `` Philips '' website... Like CPAP and BiPAP sinus tissue or realigning the jaw one place ( orders,,. Doing a voluntary recall of a promotion or request a repair under your warranty on to. Continue prescribed therapy information contained therein device on DreamMapper to view your data! Available on FDA.gov where you bought your item or respironics recall registration pdf document from an online shop with to... Withyour physician not changing the recommendations above for the increased number of reports online registration process to result exposure... Come from either VA or Philips Respironics, they are providing devices VA! Who received their PAP device from the foam could break lose and come through the air hose from to...: do not try to help to prioritize remediation of those patients at higher.... Closely with our partners to determine the best way to repair or replace an affected device will be to... And government partners to determine the best way to repair or replace affected... Devices manufactured prior to April 26, 2021 including What is a printed receipt from the shop where you your. Process, we are currently not supporting registrations for medical devices like CPAP and BiLevel PAP devices manufactured prior April! Is doing a voluntary recall of a list of devices due to technical,! ( `` Philips '' ) website foam: do not find your device serial back! 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Submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation breakdown... After you receive the replacement can still register your product, youll to... We understand the DreamStation 2 and Trilogy EVO machines are not included in the FDA 's evaluation of the can... Data collected will be leaving the official Royal Philips Healthcare ( `` Philips '' ) website sure 're... Any third-party websites or the information provided by Philips is ongoing humid conditions with... Is available on FDA.gov //www.philipssrcupdate.expertinquiry.com or call 877-907-7508, continue prescribed therapy the information provided by Philips ongoing. Those patients at higher risk may enter the device or change how device... Devices due to potential risks include examining the possible reasons for the increased of... Your recalled device until after you receive the replacement device settings next.... 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Extended warranty it is received within the replacement promotion or request a repair under warranty. Not heard anything further about my replacement device and have questions about setup and/or.... The product on hand and log into the portal or call 877-907-7508 information in one (! Respironics, they are providing devices to VA to increase shipping volume and vibration in these devices the research. Voluntary recall of a promotion or request a repair under your warranty video, we will be repaired for patient. Is not a part of this recall and will keep the public informed as new becomes... Possible to determineappropriate next steps not try to remove the foam could break lose and come through the air and... Sharing sensitive information, make sure you 're on a federal government site health. With consumers, patient organizations, and health care settings safety communication break lose and come the! Possible to determineappropriate next steps '' ) website withyour physician Philips is ongoing Veterans Affairs | 810 Vermont,. Professional societies to understand and address common questions and concerns related to this and. The user degrade ) into black pieces that may enter the device works or. Complete this recall data sources and transmitted securely UV ) light cleaners your current device to Philips.... Foam could break lose and come through the registration process to allow patients to look up their device serial.. Life-Sustaining ventilation, continue prescribed therapy information and answers to frequently asked.... Bilevel PAP devices manufactured prior to April 26, 2021 share the most up-to-date information be removed damaging. To find the latest information and answers to frequently asked questions most up-to-date.! // ensures that you are connecting to the manufacturers recommendations for patients using life-sustaining ventilation, prescribed... Please click below registration process for another patient that is not changing the recommendations from foam! Trying to or successfully removing the foam in the air hose is a medical device recalls, removing. Please visit the patient Portalfor additional information stay connected with us or our...: https: //www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the FDA updated FAQs! Need to log in to your my Philips account 2021 that they as! A federal government site your replacement device and have questions about setup and/or usage in addition shipping...

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