The potential risks of exposure due to chemical emissions from affected foam include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects. When will the correction for this issue begin? Call 1800-220-778 if you cannot visit the website or do not have internet access. 9/1/2021: Philips Respironics issued a press release indicating that the repair and replacement program of first-generation DreamStation devices in the US has started, and that the new sound abatement foam has been approved by the FDA. On September 1, 2021 Philips Respironics issued a statement 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 DreamStation 2 CPAP Advanced is designed to provide a simplified user experience, including a premium color touchscreen with fewer panes to navigate. If you do not have this letter, please call the number below. Our quality management system processes and analyis of user reports have indicated that this material may lead to patient harm and impact clinical care. The following products listed are affected by the recall notification / field safety notice: Continuous Ventilator, Minimum Ventilatory Support, Facility Use, Also known as BiPAP Hybrid A30Ventilator (A-Series), Also known as BiPAP A40 Ventilator (A-Series), Also known as BiPAP A30 Ventilator (A-Series). Can Philips replace products under warranty or repair devices under warranty? Therecall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks. ResMed CPAP, APAP, or BiPAP (BiLevel PAP) machines are safe to use. 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. Call 1800-220-778 if you cannot visit the website or do not have internet access. For information on the Recall Notice, a complete list of impacted products, and . All rights reserved. Are you still taking new orders for affected products? Contact information for innovation agency Phillips & Co. Phillips & Co. We help organizations accelerate innovation through strategy, research, ideation, design and training. Please be assured that our teams are working on a comprehensive remediation program to support patients with an affected device. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. What is the safety hazard associated with this issue? In some cases, this foam showed signs of degradation (damage) and chemical emissions. Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. In most markets, devices currently authorized for repair and replacement include DreamStation CPAP and Bi-level devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. Product Registration. As a result, testing and assessments have been carried out. Please be assured that we are doing all we can to meet demand, including increasing the production of repair kits and replacement devices. Further testing and analysis is ongoing. Philips Quality Management System has been updated to reflect these new requirements. Our quality management system processes and analyis of user reports have indicated that this material may lead to patient harm and impact clinical care. Consultation with health care providers about using an inline bacterial filter with ventilators, which may help to filter out particles of foam, as indicated in the Philips recall notification, which also notes limitations of this option and areas of caution. Whether in the judgement of the treating clinical team the benefit of continued usage of these ventilator devices may outweigh the potential risks identified in the recall notification. The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. Therecall notification (U.S. only) / field safety notice (International Markets) informs customers and users of potential impacts on patient health and clinical use related to this issue, as well as instructions on actions to be taken. Particles or other visible issues? We sincerely apologize for this disruption. This new assessment is limited to the evaluation of VOCs for first-generation DreamStation devices and does not evaluate the risks of potential foam particulates or cover other devices affected by the recall. Review of this assessment has determined that exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not typically anticipated to result in long-term health consequences for patients. Philips CPAPs cannot be replaced during ship hold. On December 8, 2022, Apria was notified by Philips Respironics of a new nationwide recall of these remediated Trilogy 100/200 ventilator devices. The FDA sent a notification order to Philips, telling the company it inadequately notified consumers about its CPAP, BiPAP and ventilator machine recall. The . Hotline to Answer Questions and Issues for Patients Who Received Replacement DevicesCall: 833-262-1871 Important Links, Documents, and FAQs from Philips Respironics Philips communications currently being mailed to patients The new material will also replace the current sound abatement foam in future products. A small percentage of machines have been confirmed to have a defect resulting in damage to an insulating foam within the blower unit. 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). This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. These could include transient potential injuries, symptoms and complications, as well as possibly serious injury which can be life-threatening or cause permanent impairment, or require medical intervention to preclude permanent impairment. Please contact your Philips representative if you are in need of a loaner Trilogy Evo device for a patient. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. In some cases, this foam showed signs of degradation (damage) and chemical emissions. RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS. If you have not done so already, please click here to begin the device registration process. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. This could affect the prescribed therapy and may void the warranty. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. The environmental conditions that may be one of the causes of this issue refer to the climate and regional temperatures of the countries where the devices are used and stored. The new material will also replace the current sound abatement foam in future products. As such, there are a lot of possible configurations. Patient safety is our top priority, and we are committed to supporting our patients, durable medical equipment providers (DMEs), distributors, home health partners, and clinicians through the complete remediation process. In the event of exposure to degraded foam: In the event of exposure to chemical emissions: Philips is notifying regulatory agencies in the regions and countries where affected products are available. All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers, Continuous Ventilator, Minimum Ventilatory Support, Facility Use. Please contact your Philips rep if you are in need of a loaner Trilogy Evo device for a patient. At that time, out of an abundance of caution and based on available information, Philips advised of potential health risks related to sound abatement . This new assessment is limited to the evaluation of VOCs for first-generation DreamStation devices and does not evaluate the risks of potential foam particulates or cover other devices affected by the recall. Call 1800-220-778 if you cannot visit the website or do not have internet access. This is a potential risk to health. Explore these homes by property type, price, number of bedrooms, size . This recall notification / field safety notice has not yet been classified by regulatory agencies. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). Please note that it is important that you only use approved cleaning methods for our devices and masks, as unapproved cleaning methods such as ozone may contribute to foam degradation. If you do not have this letter, please call the number below. We will share regular updates with all those who have registered a device. Throughout the remediation of this recall we will provide guidance and share next steps so you can ensure you have the most current and accurate information. 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). This means you can set the Ramp Plus presusre once and there is no need to restart it each night. Additionally, the notification provides details of our robust and comprehensive repair and replacement program, to correct this issue as efficiently and thoroughly as possible. Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. Or call us at: 1-800-345-6443, Options 4-6-1. 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). You are about to visit a Philips global content page. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. The Trilogy, as well as the components containing PE-PUR foam, have all been placed on hold, for potential risks as outlined in the sound abatement foam recall 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and 2) the PE-PUR foam may off-gas certain chemicals. Trilogy service instructions require PM periods as outlined for the 24 months/10,000 blower hours as well as the blower replacement. Please be assured that we are doing all we can to resolve the issue as quickly as possible. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. Are there any steps that customers, patients, users and/or clinicians should take regarding this issue? Additionally, the device Instructions for Use provide product identification information to assist with this activity. Should affected devices be removed from service? RECALL NOTICE: PHILIPS RESPIRONICS CPAP AND BIPAP DEVICES . In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks. *This number is ONLY for patients who have received a replacement machine. You are about to visit the Philips USA website. Register any Philips device you wish to have repaired/replaced. Philips Respironics intends to complete the repair and replacement programs within approximately 12 months. We thank you for your patience as we work to restore your trust. Once set, the device will automatically start at the selected Ramp Plus pressure with all future therapy sessions. Please be assured that we are doing all we can to resolve the issue as quickly as possible. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. Please contact your Philips rep if you are in need of a loaner Trilogy Evo device for a patient. The DreamStation 2 CPAP Advanced is designed to provide a simplified user experience, including a premium color touchscreen with fewer panes to navigate. If their device is affected, they should start the registration process here. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. As a result, testing and assessments have been carried out. On June 14, 2021, Philips Respironics (Philips) announced a recall for certain BiLevel Positive Airway Pressure (BIPAP), Continuous Positive Airway Pressure (CPAP), and ventilator devices due to potential health risks related to deterioration of the sound abatement foam used in these devices. Please note that once an RP kit is shipped for the affected Trilogy 100/200 device, the loaner Trilogy Evo must be returned within 45 days to avoid being charged. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. If you have not yet . The foam degradation and chemical emission issues were discovered as part of our Quality Management System processes, and are being corrected in accordance with appropriate regulatory requirements. We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. On April 26, 2021, Philips globally provided an important update to the market regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio. Outside of these hours: Please call us at 1-800-345-6443 or email us at: software.support@philips.com. At this time, Philips is unable to set up new patients on affected devices. philips src update expertinquiry. Patient safety is our top priority, and we are committed to supporting ourpatients, durable medical equipment providers (DMEs), distributors, home healthpartners, and clinicians through the complete remediationprocess. Can I trust the new foam? Philips continues to monitor reports of potential safety issues through our post-market surveillance activities as required by medical device regulations and laws in the markets in which we operate. 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