We understand that this is frustrating and concerning for patients. We ask that patients return their affected units as part of the repair and replacement program related to the recall / field safety notice. CPAP Machines & Masks, and Oxygen Concentrators - Services From . Continuous positive airway pressure (CPAP) therapy is a common treatment for obstructive sleep apnea. We also continue to partner with scientific and medical experts as part of our commitment to quality and patient safety. Phillips Respironics, a maker of respirators and CPAP machines, has recalled several CPAP breathing . As a result, testing and assessments have been carried out. As soon as we receive the device, we replace the sound abatement foam and associated air pathway blower with brand new parts. Your apnea mask is designed to let you breathe room air if the continuous air stops. Doing this could affect the prescribed therapy and may void the warranty. By the end of 2022, we expect to have completed around 90% of the production for shipments of replacement devices to patients. Based on the comprehensive testing and analysis that we have done over the past 18 months working with five independent certified laboratories, third-party experts and physicians - we now have a complete set of results for the first-generation DreamStation devices. You can view: safety recalls that have not been checked or fixed. On May 24, Philips Respironics issued a press release that provides additional context and information on the filed MDRs. 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 . Please continue to follow the recall / field safety notice instructions you have received for affected Philips Respironics Sleep & Respiratory Care devices. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. We are dedicated to working with you to come to a resolution. For example, spare parts that include the sound abatement foam are on hold. The .gov means its official.Federal government websites often end in .gov or .mil. Based on the comprehensive testing and analysis that we have done over the past 18 months working with five independent certified laboratories, third-party experts and physicians - we now have a complete set of results for the first-generation DreamStation devices. Those clips have reportedly interfered with medical metallic implants or objects in the body such as pacemakers, cardioverter defibrillators and neurostimulators. What happens when Philips receives recalled DreamStation devices? The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. Philips Respironics guidance for healthcare providers and patients remains unchanged. This Philips Respironics December 2022 update is intended to provide healthcare providers, patients, and other stakeholders with updated information on the testing results and third party confirmed conclusions to date on results and findings from testing PE-PUR foam used in recalled devices for VOCs, particulate matter (PM), and other testing such that healthcare providers have additional information to make informed decisions regarding the risk of continued use of recalled products. The latest information regarding this action can be found at our publicly available web site: https://www.philips.com/src-update. What is the status of the Trilogy 100/200 remediation? If you are like most people, you will wake up when the CPAP machine stops. You should register any affected device through the website, Philips.com/src-update, or by phone at 1-877-907-7508. As a patient, if you have registered your device, but it has not been matched to a DME provider, there may be several reasons that this has occurred. As part of our commitment to quality and patient safety, Philips Respironics is dedicated to removing product containing the affected sound abatement foam from the market. We understand that this is frustrating and concerning for patients. At the time the field safety notice was issued, Philips Respironics relied on an initial, limited data set and toxicological risk assessment. The site is secure. If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. To read more about ongoing testing and research, please click here. 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). While recalled devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam component, the sound abatement foam in all new and remediated devices is a silicone 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. Once Philips RS receives this information from your DME, we can continue to proceed with the remediation of your affected device. Based on the extensive testing and analysis that we have done over the past 18 months working with five independent certified laboratories, as well as third party experts and physicians - we now have a complete set of results** for the first-generation DreamStation devices. Jeffrey Reed, who experienced persistent sinus infections and two bouts of pneumonia while using a Philips CPAP machine, poses . You can read the press release, On May 24, Philips Respironics issued a press release that provides updated information on our comprehensive testing and research program. As part of our commitment to quality and patient safety, Philips is dedicated to removing product containing the affected sound abatement foam from the market. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Creating a plan to repair or replace recalled devices. Patients are advised to log into the Patient Portal to view approximate shipping timeframe of their replacement device. We appreciate your cooperation and patience and encourage you to save your registration confirmation number for future communications. We do not offer repair kits for sale, nor would we authorize third parties to do so. The Food and Drug Administration classified. The initial concern with the foam related to possible emission of particulates (tiny particles) from degraded foam and certain chemicals of concern, called volatile organic compounds (VOCs). For more information on the recall notification (U.S. only) / field safety notice (Outside of U.S.), as well as instructions for customers, users and clinicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update If you are a patient who has been affected by this recall, do not try to remove the foam from your device. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. Out of an abundance of caution, a reasonable worst-case scenario was considered. 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. Using alternative treatments for sleep apnea. We know the profound impact this recall has had on our patients, business customers, and clinicians. If a user has elected to preserve his/her unit and has provided the required information in the Preservation Registry at https://www.mdl3014preservationregistry.com, Philips will not charge the users DME supplier for the cost of the replacement device. You can read the press release here. What is considered a first generation DreamStation device? This means you can set the Ramp Plus presusre once and there is no need to restart it each night. Is this replacement device affected by the recall too? Using packing tape supplied, close your box, and seal it. The testing information published in December 2022 was performed on the original DreamStation device and applies to DreamStation, DreamStation BiPAP AVAPS, DreamStation BiPAP S/T, DreamStation BiPAP ASV, and E30 ventilator devices. On June 14th, the company issued a recall notice for over a dozen of its ventilators and BiPAP and CPAP machines, which are used by millions of people at home, in hospitals, and in care. The potential issue is with the foam in the device that is used to reduce sound and vibration. A recall was issued on 17 million sleep apnea masks manufactured by Philips that contain magnetic clips. When you receive your replacement device, please first be sure to review all written instructions for setup, cleaning of existing components, and return instructions. In the US, the recall notification has been classified by the FDA as a Class I recall. Also known as DreamStation BiPAP autoSV, Also known as DreamStation BiPAP AVAPS, DreamStation BiPAP S/T, Also known as System One BiPAP autoSV, System One BiPAP autoSV Advanced, Also known as System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series), Also known as BiPAP Hybrid A30Ventilator (A-Series) (not marketed in US), Also known as BiPAP V30 Auto Ventilator (A-Series), Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US), Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US). The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. Please click here for the latest testing and research information. 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. Affix the pre-paid postage label to the box and schedule a pick up at your local FedEx. A Philips CPAP recall lawsuit seeks class action status, saying the manufacturer has failed to repair or replace the expensive machines, which contain a toxic foam that could cause respiratory . 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. More information on the recall can be found via the links below. Are you still taking new orders for affected products? Repairing and replacing the recalled devices. Phone. In some cases, this foam showed signs of degradation (damage) and chemical emissions. Be sure to place your mask, tubing and SD card aside as they may be used with your replacement device. Posts: 3485. We then thoroughly clean and decontaminate the device, update the firmware, test, and repackage it with a recertified sticker to show that it is ready for use. Entering your device's serial number during registration will tell you if it is one of the recalled models . Please click, We know how important it is to feel confident that your therapy device is safe to use. Based on the comprehensive testing and analysis that we have done over the past 18 months working with five independent certified laboratories, third-party experts and physicians - we now have a complete set of results for the first-generation DreamStation devices. Half of those devices are in use in the U.S., the company said . At the time, Philips Respironics could not exclude possible carcinogenic effects with the limited dataset that was available. Foam: Do not try to remove the foam from your device. By returning your original device, you can help to make sure that it can be repaired for future use by another patient. Yes, Philips has recalled some of its ventilators, CPAP and BiPAP machines. 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. Products that are not affected may have different sound abatement foam material, as new materials and technologies have become available over time. Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. See How to Locate the Serial Number on your device on the Philips website. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. Please be assured that our teams are working on a comprehensive remediation program to support patients with an affected device. In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). CHIPPEWA FALLS, Wis. (WEAU) -Around 20 different models of ventilators, CPAP and BiPAP machines made by Philips were recalled in June because a foam inside . fact In July 2021, the FDA classified the Philips CPAP recall as a Class I recall. The foam was determined to be PE-PUR foam, the same type of foam used in Philips' devices previously recalled in June 2021. They are encouraging everyone to register their device with Philips Respironics on their website or call 877-907-7508. By returning your original device, you can help to make sure that it can be repaired for future use by another patient. If you are an established patient at Everything CPAP, know that we have already began the process of getting your machine fixed or replaced. The DreamStation 2 CPAP Advanced is designed to provide a simplified user experience, including a premium color touchscreen with fewer panes to navigate. If you have a health issue and are using or have used a recalled or replaced device or have any problem with your device, talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. With your replacement device reassembled and ready for use, return your affected device by placing it into the cardboard package in which you received your replacement device. While recalled devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam component, the sound abatement foam in all new and remediated devices is a silicone foam*. As we have previously noted in connection with the return of your DreamStation device, we will not be returning DreamStation devices back to the original user. Also, be sure to keep all packaging materials, as they will be used to return your affected device back to Philips Respironics. I have seen foam repair kits offered online at Amazon.com and elsewhere from third parties. A patient no longer needs to tap a Ramp button every night to start at the desired pressure. I've been told that I am considered "not matched" to a DME and therefore Philips RS is unable to send me my replacement device. If their device is affected, they should start the registration process here. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. This recall includes certain devices that Apria provides to our patients. 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. Learn more about Philips products and solutions for healthcare professionals. Register your device on the Philips website. Continuing to use an affected device, if a patients health care provider determines that the benefits outweigh the risks identified in the recall notification. If you have not done so already, please click here to begin the device registration process. Phone. Common problems with CPAP include a leaky mask, trouble falling asleep, a stuffy nose and a dry mouth. 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. Once all accessories have been installed, plug in your device to a working wall outlet and wait five minutes for your device settings to upload. Based on our analysis, the root cause of this issue is related to the sound abatement foam, currently used to reduce noise and vibration in specific identified products of the Sleep & Respiratory Care portfolio. It is important that you do not stop using your device without discussing with your doctor. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. Alongside this, we have expanded our pool of experts in the areas of treatment and components, including specialists in toxicology, biocompatability and chemistry. Please refer tothe FDAs guidance on continued use of affected devices. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. Check the list of devices lower on this page to see if your device is affected by this action. 1-800-229-6417 option 1. Signs of an Aging CPAP Mask: CPAP Masks should be washed daily with warm water and gentle soap or baby shampoo. After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. For more information on the recall notification (U.S. only) / field safety notice (Outside of U.S.), as well as instructions for customers, users and clinicians, affected parties may contact their local Philips representative or visit. Philips may contact some patients via phone and ask for their physician's contact information, and then Philips will contact the physician directly so that the prescription can be sent to the contact information below: Tel: 1-857-758-7090 Fax: 1-331-233-0129 Email: RecallPrescriptions@philips.com PAP Recall Guidance Based on the comprehensive testing and analysis that we have done over the past 18 months working with five independent certified laboratories, third-party experts and physicians - we now have a complete set of results for the first-generation DreamStation devices. The Food and Drug Administration (FDA) has authorized Philips to start repairing the first-generation DreamStation sleep apnea machines that were recalled in June because foam used in the devices posed health issues to consumers. Philips has established a registration process where you can look up your device serial number and begin a claim if your unit is affected. When you receive your replacement device, please first be sure to review all written instructions for setup, cleaning of existing components, and return instructions. We will share regular updates with all those who have registered a device. More information and instructions on how to register for preservation may be found at: It is important that you do not stop using your device without discussing with your doctor. Where do I find my device's serial number? The VA is sending notifications to all veterans who have been issued a device and doing what they can to spread the word about the recall. We thank you for your patience as we work to restore your trust. U.S. only: If you are looking for more information on how to use your new device and become familiar with it, you can visit www.philips.com/ds2-replacement for more information. Locate the Serial Number on Your Device. Please, On May 24, Philips Respironics issued a press release that provides additional context and information on the filed MDRs. "It's just as effective as a regular CPAP device. All oxygen concentrators, respiratory drug delivery products, airway clearance products. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Using alternative treatments for sleep apnea. No. Affix the pre-paid postage label to the box and schedule a pick up at your local FedEx. Please click here for the latest testing and research information. This also includes an in-depth review and re-assessment of data and toxicological risk-assessments prior to June 2021. Are there any recall updates regarding patient safety? [FOR WEB] Please scroll down to view photos of affected devices if you are unsure which device you currently use. I have been waiting for the replacement of my CPAP and no one has ever contacted me or email. You must register your recalled device to get a new replacement device. On May 24, Philips Respironics issued a press release that provides updated information on our comprehensive testing and research program. The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. Philips has provided this guide to help you: https://www.philipssrcupdate.expertinquiry.com/locate-serial-number Fill out the registration form at the bottom of this page: https://www.philipssrcupdate.expertinquiry.com/ The FDA developed this page to address questions about these recalls and provide more information and additional resources. I have had sleep apnea and have used a CPAP machine for years. We will share regular updates with all those who have registered a device. Philips CPAP Recall Status Following the initial recall of Philips CPAP, BIPAP and ventilator machines in June 2021, predominantly from the DreamStation line of products, an additional recall was issued in October 2022. CDRH will consider the response when it is received. If inhaled or swallowed, the emissions could cause headaches, asthma, lung problems and even cancer, the company warned in launching a massive recall. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. 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. The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. For Spanish translation, press 2; Para espaol, oprima 2. We have developed a comprehensive plan to replace the current sound abatement foam with a new material that is not affected by this issue and have already begun this process. Follow the manufacturers instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. There will be a label on the bottom of your device. Please review the DreamStation 2 Setup and Use video for help on getting started. Your prescription pressure should be delivered at this time. We do not offer repair kits for sale, nor would we authorize third parties to do so. We will keep the public informed as more information becomes available. After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. It could take a year. The American Academy of Sleep Medicine provides important safety information for patients about the Philips recall of certain PAP devices. 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. This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation. Do not stop using your device without speaking to your physician or care provider. 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. We understand that any change to your therapy device can feel significant. We are aware of the concerns raised by this information and we are sincerely apologetic for any disruption of care or inconvenience that may have been a result. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Out of an abundance of caution, a reasonable worst-case scenario was considered. How are you removing the old foam safely? We are producing and shipping similar CPAP, BiLevel PAP and Mechanical Ventilator platforms with a different design. 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. Please refer tothe, If a user has elected to preserve his/her unit and has provided the required information in the Preservation Registry at. In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). Koninklijke Philips N.V., 2004 - 2023. We also remind customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are recommended to be replaced after five years of use. Philips will then confirm that your device is one of the recalled models and advise you about your next steps. As a first step, if your device is affected, please start the registration process here. If you are used to using a DreamStation CPAP device and have received a new DreamStation 2 CPAP Adanced, this new device has also been set to the same prescription settings as before and is ready for use. How long will I have to wait to receive my replacement device? This could affect the prescribed therapy and may void the warranty. This Philips Respironics December 2022 update is intended to provide healthcare providers, patients, and other stakeholders with updated information on the testing results and third party confirmed conclusions to date on results and findings from testing PE-PUR foam used in recalled devices for VOCs, particulate matter (PM), and other testing such that healthcare providers have additional information to make informed decisions regarding the risk of continued use of recalled products. 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. The Philips recall website has a form for you to enter your device's serial number. You'll receive a new machine when one is available. The potential issue is with the foam in the device that is used to reduce sound and vibration. If you have a DME and have not already, please contact notify them that they need to register your affected device serial number so that we can match you to your DME and continue the process. People with sleep apnea and other ailments who rely on CPAP and more than a dozen devices made by . Please visit theventilation news and updates pageforthe latest status of the Trilogy 100/200 remediation. Can I trust the new foam? To continue use of your device due to lack of alternatives, consult with your physician to determine if the benefit . Working to reach everyone affected so they understand the situation and know what they need to do, starting with the registration of the affected devices. Based on the comprehensive testing and analysis that we have done over the past 18 months working with five independent certified laboratories, third-party experts and physicians - we now have a complete set of results for the first-generation DreamStation devices. Patients, physicians and durable medical equipment (DME) suppliers can call Philips at 877-907-7508 for additional support. The potential issue is with the foam in the device that is used to reduce sound and vibration. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Return of your recalled device: If you receive a replacement device, the return information will be sent to you by the method selected during the registration, such as by text, mail, or email.
