The recall 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. Sheridan Memorial Hospital has been advised of a worldwide voluntary recall of various continuous positive airway pressure machines (CPAP), BiLevel positive airway pressure machines (BiPAP) and mechanical ventilators that are manufactured by Philips Respironics.This recall is being conducted due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in . During these preventative maintenance periods, the service requires replacement of the PE-PUR foam components. 27 votes, 26 comments. December 2022 update on completed testing for first-generation DreamStation devices, Jan Kimpen, Chief Medical Officer, discusses what the test results mean for healthcare providers and their patients, Jan Bennik, Head of Test and Research Program, explains the details behind the testing results. 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. 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. The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. Manage your accounts from anywhere, anytime. If you do not have this letter, please call the number below. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. The company has developed a comprehensive plan for this correction, and has already begun this process. Once set, the device will automatically start at the selected Ramp Plus pressure with all future therapy sessions. The FDA has classified . To resolve this situation as quickly as we can, we are doing the following: Patients who are concerned should check to see if their device is affected. At this time, Philips is unable to set up new patients on affected devices. As a result, testing and assessments have been carried out. This means you can set the Ramp Plus presusre once and there is no need to restart it each night. Will existing patient devices that fail be replaced? Call 1800-220-778 if you cannot visit the website or do not have internet access. Philips is committed to rectfying this issue through a robust and comprehensive repair and replacement program. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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 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. 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. After registration, we will notify you with additonal information as it becomes available. The LCSMK1 is for the Surefire ST-07 or UE-07 tape switch. Consult your Instructions for Use for guidance on installation. The issue is with the foam in the device that is used to reduce sound and vibration. Over our 10 plus year relationship, we have always considered Phillips Industries a strategic partner and one of our primary product lines we introduce to our customer. 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. 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. We understand that any change to your therapy device can feel significant. PHILIPS RESPIRONICS PAP DEVICE RECALL INFO: Updated 03/11/2022 (updates are in bold) Update March 14, 2022: In response to numerous reports of problems people have had Philips CPAPs cannot be replaced during ship hold. Our intention is to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. The website provides current information on the status of therecall notification (U.S. only) / field safety notice (International Markets) and how to receive permanent corrective action to address the two issues. January 20, 2022 . Users should consult with their physicians as directed in the recall notification (U.S. only) / field safety notice (International Markets). This could affect the prescribed therapy and may void the warranty. As part of the remediation process, customers and patients will be provided with more information on the next steps to implement the permanent solution as it becomes available. ** Philips Respironics has provided the data and analyses to the FDA and other competent authorities. 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. We are committed to providing you information and resources for your own understanding, but also to help you communicate with your patients effectively and efficiently. If your machine was not purchased from us, you can still use the link below to register your machine with Respironics, but you will also need to contact your original supplier as well. We thank you for your patience as we work to restore your trust. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. 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. Our trained service professionals can make sure that the affected foam is completely and safely removed, and that the new silicone foam is inserted correctly. 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. Please contact your Philips rep if you are in need of a loaner Trilogy Evo device for a patient. Outside of these hours: Please call us at 1-800-345-6443 or email us at: software.support@philips.com. For more information on the recall notification, as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit. This means you can set the Ramp Plus presusre once and there is no need to restart it each night. As a result of extensive ongoing review, on June 14 . 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. Click the link below to begin our registration process. How are you removing the old foam safely? 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. 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. Are there any steps that customers, patients, users and/or clinicians should take regarding this issue? 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. Philips has completed our analysis in accordance with our Quality Management System and identified all affected products, which are included in our notifications to regulatory agencies and customers. All oxygen concentrators, respiratory drug delivery products, airway clearance products. Therecall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods. Continuing to use an affected device, if a patients health care provider determines that the benefits outweigh the risks identified in the recall notification. In June 2021, after discovering apotential health risk related to a part in certain CPAP, BiPAP and MechanicalVentilator devices, Philips issued a voluntary Field Safety Notice (outsideU.S.) / voluntary recall notification (U.S. only). kidneys and liver) and toxic carcinogenic affects. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. When can Trilogy Preventative Maintenance be completed? For example, spare parts that include the sound abatement foam are on hold. Order Related Inquiries . The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. RECALL NOTICE: PHILIPS RESPIRONICS CPAP AND BIPAP DEVICES . At this time, Philips is unable to set up new patients on affected devices. Updated as of 9/1/2021. The company has dedicated significant resources to address this issue, and has developed a comprehensive plan for this correction, and has already begun this process. Patients who have received their replacement device and are in need of Customer Support should call: 833-262-1871. Further testing and analysis is ongoing. 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. *Trilogy Evo devices provided as loaners do not contain the silicone foam or the affected PE-PUR foam. The FDA sent a notification order to Philips, telling the company it inadequately notified consumers about its CPAP, BiPAP and ventilator machine recall. Home; Quem somos; Produtos. If your physician determines that you must continue using this device, use an inline bacterial filter. 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. Philips is deploying a permanent corrective action to address the two (2) issues described in the Recall Notice mentioned above. 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. 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). Frequently updating everyone on what they need to know and do, including updates on our improved processes. If you are a patient who has been affected by this recall, do not try to remove the foam from your device. 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 Theremediation of this field safety notice is underway and has started for the following devices: Philips aims to address allaffected devices within the scope of this field safety notice but due to thevolume of devices that have been affected, we regret it may take some time torepair or replace patients' devices. Even Auto ON is enabled so that all you have to do is put your mask on and start breathing. Are you still taking new orders for affected products? 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. 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. Are affected devices continuing to be manufactured and/or shipped? Philips Respironics guidance for healthcare providers and patients remains unchanged. Philips Respironics received authorization from the U.S. Food and Drug Administration (FDA) to replace the . Consult your Instructions for Use for guidance on installation. Please note that it is important that you only use approved cleaning methods for our devices and masks, as, We know how important it is to feel confident that your therapy device is safe to use. Has Philips received any reports of patient harm due to this issue? While there have been limited reports of headache, upper airway irritation, cough, chest pressure and sinus infection that may have been associated with the foam, based on lab testing and evaluations, it may be possible that these potential health risks could result in a wide range of potential patient impact. Trilogy service instructions require PM periods as outlined for the 24 months/10,000 blower hours as well as the blower replacement. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. 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. Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use. Quietest CPAP: Z2 Auto Travel CPAP Machine. We are not taking new orders at this time, and we have stopped all new shipments temporarily, in order to support the field safety notice. This video shows how the patient (device user) can check if their Philips Sleep and Respiratory Care medical device is affected by the recall and if so, how . Please be assured that we are doing all we can to meet demand, including increasing the production of repair kits and replacement devices. The FDA is still considering the data and analyses that Philips Respironics has provided and may reach different conclusions. 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. How did this happen, and what is Philips doing to ensure it will not happen again? As a result, testing and assessments have been carried out. Contact us to let us know you are aware of the Philips recall (if you have not already). IF YOU HAVE NOT DONE SO - PLEASE REGISTER YOUR MACHINE NOW. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. 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. Philips Respironics intends to complete the repair and replacement programs within approximately 12 months. PAPs are assigned to clients by Philips and are sent to us at random; we will . Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods. Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods. Call 1800-220-778 if you cannot visit the website or do not have internet access. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. Click the link below for additional clinical details on the issue and other information to help you advise your patients who have been impacted. Or call us at: 1-800-345-6443, Options 4-6-1. Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. Affected devices may be repaired under warranty. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. The . Using alternative treatments for sleep apnea. 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. 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. The FDA reported it received more than 69,000 device complaints, including 168 deaths, related to recalled Philips devices since April 2021. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. Philips has completed our analysis in accordance with our Quality Management System and identified all affected products, which are included in our notifications to regulatory agencies and customers. French, Spanish, and Portuguese will be automatically translated for English speaking support . To resolve this situation as quickly as we can, we are doing the following: 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. In those regions where Philips provides both patient care and devices, will new patients be set up with devices? You can find the list of products that are not affected here. Philips recognizes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. Are customers entitled to warranty replacement, repair, service or other mitigations? Please be assured that we are treating this matter extremely seriously, and are working to address this issue as efficiently and thoroughly as possible. Canada; Ontario; Brampton; Westgate Real Estate; City Guide Real Estate & MLS Listings in Westgate, Brampton . Using alternative treatments for sleep apnea. Philips has been in full compliance with relevant standards upon product commercialization. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Philips CEO Frans van Houten and Chief Business Leader Connected Care Roy Jakobs talk about the various aspects of the field safety notice, Technical Project Manager Jan Bennik speaks about the test and research program, Durable Medical Equipment Providers, Distributors, or Medical Institutions, Template web copy block for DME and HCP use, Physician engagement letter for DME and HCP use, Physicians and other medical care providers. Phillips Industries stands for everything we believe and comes to market with innovation and quality. 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