Philips Respironics will continue with the remediation program. We strongly recommend that customers and patients do not use ozone-related cleaning products. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. 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. How will Philips address this issue? 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. We have established a claims processing and support center to assist you. Register any Philips device you wish to have repaired/replaced. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. Can Philips replace products under warranty or repair devices under warranty? We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. 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. Is this a recall? We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. 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 . 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. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. 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 foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. 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. Inovao em bombas sem selo. All rights reserved. We know how important it is to feel confident that your therapy device is safe to use. Click the link below to begin our registration process. 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. We thank you for your patience as we work to restore your trust. We would like to inform our Sleep Care patients and community of the recall so action can be taken as needed. 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. How long will it take to address all affected devices? 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. Philips is committed to rectfying this issue through a robust and comprehensive repair and replacement program. You can find the list of products that are not affected here. 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Call 1800-220-778 if you cannot visit the website or do not have internet access. For patients using life-sustaining mechanical ventilator devices: For patients using BiLevel PAP and CPAP devices: We cannot stress enough that Philips is treating this matter with the highest possible seriousness, and are dedicating significant time and resources to address this issue. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. 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. 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. When will the correction for this issue begin? 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. Call 1800-220-778 if you cannot visit the website or do not have internet access. This is a potential risk to health. 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 affected products are identified in the tables below: All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers, DreamStation ASV DreamStation ST, AVAPS SystemOne ASV4 C-Series ASV C-Series S/T and AVAPS OmniLab Advanced+, SystemOne (Q-Series) DreamStation DreamStation Go Dorma 400 Dorma 500 REMstar SE Auto, Trilogy 100 Trilogy 200 Garbin Plus, Aeris, LifeVent, A-Series BiPAP Hybrid A30 (not marketed in US) A-Series BiPAP V30 Auto, A-Series BiPAP A40 (not marketed in the US) A-Series BiPAP A30 (not marketed in the US). Are customers entitled to warranty replacement, repair, service or other mitigations? 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. Earlier this week, Philips Respironics announced the recall of certain medical devices, including Continuous Positive Airway Pressure (CPAP) and BiLevel Positive Airway Pressure (BPAP/BiLevel PAP) devices, and mechanical ventilators. Philips is notifying regulatory agencies in the regions and countries where affected products are available. 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. The . Further testing and analysis is ongoing Please note that it is important that you only use approved cleaning methods for our devices and masks, as. 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. What is the safety issue with the device? 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. June 2021: Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen. 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 . Philips Sleep and Respiratory Care Devices - Australia and New Zealand. Are there any steps that customers, patients, and/or users should take regarding this issue? 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. Best Value: 3B Medical Luna II Auto. Trilogy service instructions require PM periods as outlined for the 24 months/10,000 blower hours as well as the blower replacement. As a result of extensive ongoing review, on June 14 . For patients using life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed therapy until you have talked to your physician. Philips has determined that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone), and certain environmental conditions involving high humidity and temperature. A small percentage of machines have been confirmed to have a defect resulting in damage to an insulating foam within the blower unit. 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). By clicking on the link, you will be leaving the official Philips Electronics Ltd. ("Philips") website. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. Further testing and analysis is ongoing. 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 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. Philips deeply regrets the inconveniences caused by this issue, and we are dedicating significant time and resources to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. Philips Respironics received authorization from the U.S. Food and Drug Administration (FDA) to replace the . Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 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. 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. This is a potential risk to health. 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