In the US, the recall notification has been. 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. Philips Respironics has issued a . 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 Respironics is doing a voluntary recall of a list of devices due to potential risks. You are about to visit the Philips USA website. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. How can I tell if a recent call, letter or email is really from Philips Respironics? Didn't include your email during registration? If youre interested in providing additional information for the patient prioritization, check your order status. 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. 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. To decide on the next steps, discuss the benefits and risks based on your individual health situation with your health care provider, such as your primary care physician or sleep doctor. benefits outweigh the risks identified in the recall notification. 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. The data collected will be used to help to prioritize remediation of those patients at higher risk. Cleaning, setup and return instructions can be found here. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. The site is secure. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. 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. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. 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. Images may vary. 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 . The FDA's evaluation of the information provided by Philips is ongoing. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. 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. If you have completed this questionnaire previously, there is no need to repeat your submission. I need to change my registration information. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. Lifestyle Measures to Manage Sleep Apnea fact sheet. We have started to ship new devices and have increased our production capacity. 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. Irritation to the skin, eyes, nose, and respiratory tract (airway), Toxic or cancer-causing effects to organs, such as kidneys and liver, Irritation in the eyes, nose, respiratory tract (airway), and skin, Hypersensitivity reaction, such as an allergic reaction or another immune system reaction. Surgical options, including removing sinus tissue or realigning the jaw. No. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. 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. Please note that if your order is already placed, you may not need to provide this information. More information is available at http://www.philips.com/src-update. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. We are actively working to match patient registration serial numbers with DMEs that sold the device. Be aware that during the manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). The full report is available here. have hearing loss. 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. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Well start processing your replacement device order once: Your device registration is matched to your DME A device becomes available 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. 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. 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 Share sensitive information only on official, 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. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. Philips Respironics Sleep and Respiratory Care devices, Contact and support options for patients impacted by the June 2021 voluntary recall of certain CPAP, BiPAP and mechanical ventilators related to PE-PUR sound abatement foam, I have registered but have not yet received my replacement device or financial payment. Only clean your device according to the manufacturers recommendations. Secure .gov websites use HTTPS 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. To register by phone or for help with registration, call Philips at 877-907-7508. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. 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. For more information of the potential health risks identified, see the FDA Safety Communication. Keep your registration confirmation number. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Can we help? We may request contact information, date of birth, device prescription or physician information. The relevant heath information that will be asked includes: 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 with several partners to improve responsiveness and we are using their email domain names in some communications, including: Koninklijke Philips N.V., 2004 - 2023. 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. Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. If you do not find your device on the list of recalled models or during registration: You may want to contact the medical equipment supplier (commonly known as a Durable Medical Equipment (DME) supplier) who gave you your device. To register a new purchase, please have the product on hand and log into your My Philips account. We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. Apologize for any inconvenience. classified by the FDA as a Class I recall. Although MDRs are a valuable source of information, this passive surveillance system has limitations. This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. %PDF-1.7 % If you have been informed that you can extend your warranty, first you need a My Philips account. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. 2. Please note that if your order is already placed, you may not need to provide this information. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. ) or https:// means youve safely connected to 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. Creating a plan to repair or replace recalled devices. 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. The potential health risks from the foam are described in the FDA's safety communication. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. 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. . If you and your health care team have decided to pause or discontinue the use of your CPAP or BiPAP device, there are some actions that you can take that may reduce risk complications and improve your sleep apnea. Veterans Crisis Line: 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? Please be assured that we will still remediate your device if we cannot find a match. You are about to visit the Philips USA website. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Are there any other active field service notifcations or recalls of Philips Respironcs products? There were no reports of patient injury or death among those 30 MDRs. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. 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. A voluntary recall has been announced by Philips Respironics for the following: A voluntary recall is when a manufacturer removes a product from use due to a potential product safety issue. This will allow all end users to make informed decisions regarding the risks of continued use of the Recalled Products while awaiting a replacement device. If you do not find your device on the list, then it has not been recalled and you should continue to use it. Please note: only certain devices made by Philips are subject to this recall. 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. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. 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. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. When the PE-PUR foam breaks down, it may: The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include: The potential risks of inhaling chemicals released into the device's air tubes from the PE-PUR foam include: During the 2021 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 VOCs. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. For patients using life-sustaining ventilation, continue prescribed therapy. 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). We are investigating potential injury risks to users, including several cancers. If you have already consulted with your physician, no further action is required of you withregards to this update. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. 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. Learn more at www.vcf.gov . Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. Our Prescription Team is required to review all prescriptions. Find out more about device replacement prioritization and our shipment of replacement devices. Do not stop or change ventilator use until you have talked to your health care provider. Please switch auto forms mode to off. 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). Membership. Philips has pre-paid all shipping charges. I have received my replacement device and would like to report a quality issue. 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. 2. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . Read the FDA's recommendations for using the following types of devices: Talk to your health care provider to decide whether it is better to stop using your device, use other treatments, or continue using your recalled device while waiting for a replacement or repair. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. 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). You can also visit philips.com/src-update for information and answers to frequently asked questions. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. 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. 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 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. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. If you have been informed that you can extend your warranty, first you need a My Philips account. Lock Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. Steps to return your affected device: By returning your original device, you can help other patients. We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. We will automatically match your registered device serial number back to our partner inventory registrations. We recommend you upload your proof of purchase, so you always have it in case you need it. 272 0 obj <> endobj How can I tell if a recent call, letter or email is really from Philips Respironics? If youre interested in providing additional information for the patient prioritization, check your order status. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. You can also upload your proof of purchase should you need it for any future service or repairs needs. CHEST Issues Joint Statement in Response to Philips Device Recall . Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. How can I register my product for an extended warranty? Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. The FDA 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Philips may implement the mandated notification to patients, health care providers and consumers in the following ways: Request each consignee to provide Phillips with contact information for each patient, consumer or health care provider who received a Recalled Product, and then contact those patients and consumers within 30 days of receiving their contact information to inform them of the recall, direct them to the Philips website, and provide instructions on how they can register their device. 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. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. Repairing and replacing the recalled devices. To register your product, youll need to log in to your My Philips account. The FDA has reached this determination based on an overall benefit-risk assessment. Attention A T users. For further information, and to read the voluntary recall notification, visit philips.com/src-update. *. Contact and support for Philips Respironics voluntary recall Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. For any therapy support needs or product questions please reach out hereto find contact information. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. 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, and the FDA will communicate those results to the public as soon as they are available. 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/ Follow the recommendations above for the recalled devices used in health care settings. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. 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 , no further action is required of you withregards to this recall share the up-to-date... An affected device, the information provided by Philips is ongoing with silicone-based foam as of! Have increased our production capacity for any future service or repairs needs prominently displayed on... Find the latest version of Microsoft Edge, Google Chrome or Firefox you... Prescription or physician information company takes appropriate steps to correct the products increased our production capacity and Trilogy machines. A list of devices due to potential risks ventilator has an inline filter. Which fit like a sports mouth guard or an orthodontic retainer log in to your health care about. Repair and replace program. until you have talked to your health care provider about plan. Trilogy EVO machines are not included in the us, the recall notification, visit philips.com/src-update for and... The totality of information, this passive surveillance system has limitations, we are aware that Philips Respironics doing! 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