The DreamStation 2 CPAP Advanced is designed to provide a simplified user experience, including a premium color touchscreen with fewer panes to navigate. 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 src update expertinquiry; philips src update expertinquiry. 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. Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. 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. 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. 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. Domain. Therefore, PM service cannot be completed until we have authorization for the new foam design with Trilogy. 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 will provide further updateson the remediation of this field safety notice, including updates on other affected models. 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. As a result, testing and assessments have been carried out. 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. Date: June 17, 2022. On Friday July 2 2021, following consultation with the Therapeutic Goods Administration (TGA) and Medsafe, Philips Australia and New Zealand announced it is conducting an Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand for the specific affected devices. Note: Tape switch is not included. Please be assured that we are doing all we can to resolve the issue as quickly as possible. If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. 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. Trilogy service instructions require PM periods as outlined for the 24 months/10,000 blower hours as well as the blower replacement. 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 be assured that we are treating this matter extremely seriously, and are working to address this issue as efficiently and thoroughly as possible. The company will replace the current sound abatement foam with a new material that is not affected by this issue, and has already begun this process. After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. Contact us by email at info@cpapoutlet.ca, phone 1-855-542-2727 or LiveChat. Particles or other visible issues? We know the profound impact this recall has had on our patients, business customers, and . 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. 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. Philips has been in full compliance with relevant standards upon product commercialization. The . With these convenient features of online banking, it's now even easier to manage your money from anywhere at anytime. We have trained service professionals on hand who can make sure that the affected foam is completely removed, safely, and that the new silicone foam is inserted correctly. 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. 5th October 2021 Thankfully, some very long awaited positive news! 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. Philips Respironics initially recalled Trilogy 100 and 200 devices on June 14, 2021, and they subsequently began to repair these devices by installing new sound abatement foam. For Original Equipment Manufacturers (Ballasts, Drivers, Modules, and Controls) As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. The new material will also replace the current sound abatement foam in future products. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. 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. 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 we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. The affected products are identified in the tables below: A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP A40 (not marketed in the US), A-Series BiPAP A30 (not marketed in the US), Products that are not affected may have different sound abatement foam material, as new materials and technologies have become available over time. Philips Quality Management System has been updated to reflect these new requirements. Preventive maintenance for Trilogy has been paused until the new silicone foam is authorized and available. We thank you for your patience as we work to restore your trust. 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. 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. Please be assured that we are doing all we can to resolve the issue as quickly as possible. Philips is deploying a permanent corrective action to address the two (2) issues described in the Recall Notice mentioned above. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. Have regulatory authorities classified the severity of the recall? If your physician determines that you must continue using this device, use an inline bacterial filter. 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. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. Once set, the device will automatically start at the selected Ramp Plus pressure with all future therapy sessions. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. For example, spare parts that include the sound abatement foam are on hold. Phone: 800.793.1261 | Fax: 800.962.1611. For more information on the recall notification (U.S. only) / field safety notice (International Markets), as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update. 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. Additionally, the notification provides details of our robust and comprehensive repair and replacement program, to correct this issue as efficiently and thoroughly as possible. 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. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . We understand that this is frustrating and concerning for patients. What is meant by "high heat and humidity" being one of the causes of this issue? 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. Healthcare providers, patients, and other stakeholders should use the complete update, including information on the limitations of the testing, for any informed decision making and should not solely rely on the overview presented 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. Dreamstation devices were not exposed to ozone cleaning affected devices with a new blower and air pathway we! 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