A .gov website belongs to an official government It is important to register your affected device in order to understand the remediation options for your affected device. organization in the United States. 2. You are about to visit the Philips USA website. The .gov means its official.Federal government websites often end in .gov or .mil. secure websites. Learn more at www.vcf.gov . Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. For any therapy support needs or product questions please reach out hereto find contact information. Foam: Do not try to remove the foam from your device. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. That will allow them place an order for your supplies. Creating a plan to repair or replace recalled devices. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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. CHEST Issues Joint Statement in Response to Philips Device Recall . Trying to or successfully removing the foam may damage the device or change how the device works. 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. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. 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. Lock In the US, the recall notification has been. Other potential risks identified by Philips Respironics from degraded foam exposure include: Skin, eye and respiratory irritation, headache, asthma, adverse effects to other organs (e.g. hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX h?>~LJ3AF E : Create account Create an account Already have an account? Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. At this time, the FDA has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. %%EOF 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 youre interested in providing additional information for the patient prioritization, check your order status. The FDA is committed to assuring that Philips takes appropriate steps to correct the devices, working with other manufacturers and government partners to try to help make available more CPAP and BiPAP machines, and addressing concerns and questions raised by patients and health care providers about device replacement. Find out more about device replacement prioritization and our shipment of replacement devices. The devices are used to help breathing. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. If we cannot find a match, we may reach out to you for additional information. have hearing loss. Philips Respironics Sleep and Respiratory Care devices, 2. 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. 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. If you use one of these recalled devices, follow the recommendations listed below. A lock ( 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. Before sharing sensitive information, make sure you're on a federal government site. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. 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. On June 14, 2021, Royal Philips' subsidiary, Philips Respironics, initiated a voluntary recall notification * for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. 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. 0 PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. I would like to learn more about my replacement device. VA clinical experts are working with the FDA and the manufacturer to understand those risks. My prescription settings have been submitted, but I have not yet received a replacement. 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. Not yet registered? Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. You can log in or create one. The silicone foam material used to replace the PE-PUR foam in the reworked ventilators may potentially move and block the airpath, which may reduce air flow in the ventilator and could also cause the device to alarm. I have received my replacement device and would like to report a quality 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. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. In the US, the recall notification has been classified by the FDA as a Class I recall. The DME supplier can check to see if your device has been recalled. Our Prescription Team is required to review all prescriptions. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. 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. Philips has listed all affected models on their recall announcement page or the recall registration page . In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. Selected products First, determine if you are using one of the affected devices. In the US, the recall notification has been classified by the FDA as a Class I recall. The data collected will be used to help to prioritize remediation of those patients at higher risk. 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 site is secure. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. 2. Very small particles from the foam could break lose and come through the air hose. If you have a health issue, including those listed under potential health risks below, or any problem with your device, talk to your health care provider and. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. 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. 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. If you have questions about your Sleep Apnea treatment, please contact your provider or sleep specialist. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. The FDA's evaluation of the information provided by Philips is ongoing. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. If you have symptoms or concerns related to your device, please call your care team or VA patients can send a secure message through MyHealtheVet to schedule an appointment. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. Since April 2021, the FDA has received more than 98,000 MDRs, including 346 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown. 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. 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. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. 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. This recall is for issues related to deterioration of the sound abatement foam used in these devices and affects CPAP and BiLevel PAP devices manufactured before April 26, 2021. 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 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 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. 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