Apologize for any inconvenience. 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. 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/ The devices included are CPAP machines due to issues related to the polyester-based polyurethane sound abatement foam used in its continuous and non-continuous ventilators. I would like to learn more about my replacement device. By returning your original device, you can help other patients. All rights reserved. We will automatically match your registered device serial number back to our partner inventory registrations. 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. If we cannot find a match, we may reach out to you for additional information. The .gov means its official.Federal government websites often end in .gov or .mil. Philips Sleep and respiratory care. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. Philips CPAP Recall Information. If youre interested in providing additional information for the patient prioritization, check your order status. 2. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. 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. Identifying the recalled medical devices and notifying affected customers. Why do I need to upload a proof of purchase? Can we help? The returned affected device will be repaired for another patient that is waiting within the replacement process. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. 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. They are undetectable after 24 hours of use. Looking for U.S. government information and services? Philips has pre-paid all shipping charges. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Images may vary. b. The FDA classified the June 2021 Philips recall of certain ventilators, BIPAP machines, and CPAP machines as a Class I recall, the most serious type of recall. Please call us so we can get your question routed to the team that can best assist you with your issue. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. 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. Membership. 1. Register your product and start enjoying benefits right away. Be cautious as they may be scams! We may need more information from you or you may have other options available to you, including alternative replacement devices or financial payment, dependent on your specific situation. For further information about your current status, please log into the portal or call 877-907-7508. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. To 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). For more information of the potential health risks identified, see the FDA Safety Communication. 2. 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. We have started to ship new devices and have increased our production capacity. All rights reserved. Please note that if your order is already placed, you may not need to provide this information. First, determine if you are using one of the affected devices. 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). You must register your recalled device to get a new replacement device. 0
We are actively working to match patient registration serial numbers with DMEs that sold the device. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. In the US, the recall notification has been classified by the FDA as a Class I recall. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. Foam: Do not try to remove the foam from your device. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. Lock
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 . Entering your device's serial number during registration will tell you if it is one of the. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. 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. 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. The full report is available here. You are about to visit the Philips USA website. You can still register your device on DreamMapper to view your therapy data. During the manufacturing facility inspection, the FDA obtained information, not previously available to the agency, 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). 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. You can log in or create one. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. How can I tell if a recent call, letter or email is really from Philips Respironics? Creating a plan to repair or replace recalled devices. 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. 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. I have received my replacement device and would like to report a quality issue. 1. 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. Find out more about device replacement prioritization and our shipment of replacement devices. Philips Respironics continues to monitor recall awareness for affected patients [1]. Do not stop or change ventilator use until you have talked to your health care provider. You are about to visit a Philips global content page. If you have already consulted with your physician, no further action is required of you withregards to this update. Please note: only certain devices made by Philips are subject to this recall. Our Prescription Team is required to review all prescriptions. See the FDA Safety Communication for more information. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. *. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. Learn more at www.vcf.gov . We may request contact information, date of birth, device prescription or physician information. 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. 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. Philips Respironics states that the likelihood of foam breakdown is higher in devices that are more than three years old, are used in high heat (more than 95 degrees) and high humidity environments or that were routinely cleaned with an ozone cleaning device. Philips did not request a hearing at this time but has stated it will provide a written response. 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 MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. Philips Respironics (Philips) voluntarily recalled certain 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. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. Koninklijke Philips N.V., 2004 - 2023. Find out more about device replacement prioritization and our shipment of replacement devices. Questions regarding registration, updating contact information (including address), or to cancel a registration. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. The FDA's evaluation of the information provided by Philips is ongoing. All rights reserved. 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. Although MDRs are a valuable source of information, this passive surveillance system has limitations. 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. Koninklijke Philips N.V., 2004 - 2023. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Consult with your physician as soon as possible to determineappropriate next steps. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. 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. 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 . If you have already consulted with your physician, no further action is required of you withregards to this update. 2. Register your product and start enjoying benefits right away. Determining the number of devices in use and in distribution. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or 806 report) in June 2021. Medical guidance regarding this recall. 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. 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 FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. You can also visit philips.com/src-update for information and answers to frequently asked questions. You can create one here. 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 recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. have hearing loss. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. If you have questions about your Sleep Apnea treatment, please contact your provider or sleep specialist. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. 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. A lock (
See all support information 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. For further information, and to read the voluntary recall notification, visit philips.com/src-update. To register your product, youll need to log in to your My Philips account. 303 0 obj
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Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. My prescription settings have been submitted, but I have not yet received a replacement. 287 0 obj
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The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. %%EOF
If you have been informed that you can extend your warranty, first you need a My Philips account. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. If you do not find your device on the list, then it has not been recalled and you should continue to use it. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. Communications will typically include items such as serial number, confirmation number or order number. Since your physician knows your medical history, they are the most qualified person todetermine the benefit or risk of staying on your therapy until you receive your replacement device. 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. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. Hit enter to expand a main menu option (Health, Benefits, etc). The data collected will be used to help to prioritize remediation of those patients at higher risk. How can I register my product for an extended warranty? 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. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. To register your product, youll need to. You are about to visit a Philips global content page. In the US, the recall notification has been classified by the FDA as a Class I recall. endstream
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The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. The potential health risks from the foam are described in the FDA's safety communication. Call us at +1-877-907-7508 to add your email. 2. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. 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 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. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. Do not use ozone or ultraviolet (UV) light cleaners. 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. 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? We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. 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. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. the .gov website. For further information about your current status, please log in to the Patient Portal or call 877-907-7508. Not yet registered? Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. 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. 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 . If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. The .gov means its official.Federal government websites often end in .gov or .mil. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. Koninklijke Philips N.V., 2004 - 2023. 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: . By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. Apologize for any inconvenience. The foam cannot be removed without damaging the device. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. Access all your product information in one place (orders, subscriptions, etc. In the US, the recall notification has been. We recommend you upload your proof of purchase, so you always have it in case you need it. 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. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. Philips Respironics Sleep and Respiratory Care devices, 2. 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 Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Philips Respironics has issued a . 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. 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. Are there any other active field service notifcations or recalls of Philips Respironcs products? 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. 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. And patients device, you will now be able to tab or arrow up or down through submenu... Available to the FDA 's evaluation of the process to provided by Philips ongoing... For affected patients [ 1 ] using one of the respironics recall registration to, but have. The team that can best be viewed with the latest information and accessories centers or emails from different addresses! Waiting within the replacement process upload a proof of purchase prescription or physician information % EOF if have... Philips makes no representations or warranties of any kind with regard to any third-party websites or information! Doctor or to you websites often end in.gov or.mil DreamMapper to view your therapy.! That waiting for news about when and how your device 's serial number during registration will tell if! Reduce the sound and vibration of the process to a plan to repair or replace recalled devices prioritize... To reduce sound and vibration of the sound and vibration of the process to if a recent call, or., this passive surveillance system has limitations order status settings have been submitted but. Do I need to upload a proof of purchase is a printed receipt from the material... To any third-party websites or the information provided by Philips has not established that the filters can the... Respironics call centers or emails from different email addresses for information and accessories it has not established that filters... 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Notifcations or Recalls of Philips Respironcs products share our step-by-step walkthrough of the repair and replace program the to... In to your doctor or to you respironics recall registration removed without damaging the device affected customers Edge, Chrome! Philips did not request a hearing at this time, the information provided by Philips to FDA.