I submitted my prioritization information some time ago, why havent I received my replacement device yet? unapproved cleaning methods such as ozone may contribute to foam degradation. We will continue to provide regular updates to you through monthly emails. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR 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. This statement contains certain forward-looking statements with respect to the financial condition, results of operations and business of Philips and certain of the plans and objectives of Philips with respect to these items. A patient no longer needs to tap a Ramp button every night to start at the desired pressure. Information for patients and caregivers | Philips For example, as directed by FDA, Philips has prominently published information on the risk of using ozone cleaners on the landing page of the Philips Respironics field action website. Philips Respironics CPAP, BiPAP, and Ventilator Recall: FAQs Called Zix and they were able to trace their logs to confirm the email and the portal link in the email are legit. Philips generated 2021 sales of EUR 17.2 billion and employs approximately 78,000 employees with sales and services in more than 100 countries. Philips Sleep and respiratory care. Philips provides update on recall notification - News | Philips You can find the list of products that are not affected here. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Phillips recall website ; FDA notice; Frequently Asked Questions You can find the Patient Portal here. 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. Koninklijke Philips N.V., 2004 - 2023. Deaths reported with Philips ventilators, sleep apnea machines still Philips is working cooperatively with the FDA and other competent authorities to update them on new test data as they become available. Relative to other patients affected by the field corrective action, some patients health conditions may potentially place them at higher risk if sleep therapy is discontinued or if exposed to particulate breakdown. [1] Philips Respironics monthly surveys indicate that nearly 80% (aggregate data) of responding Philips Respironics CPAP users in the US confirmed they were aware of the recall. Philips Respironics Sleep and Respiratory Care devices, The Patient Portal: Why you should use it and what to expect. 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). In the interim, in specific markets, a Trilogy Evo device can be made available for patients currently using affected Trilogy 100 and 200 devices. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. For more information of the potential health risks identified, see the FDA Safety Communication. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. The DreamMapper notification function is used to direct patients/consumers back to the field action website, which includes detailed information on the field action and the process for registering, and maintaining such registration, for a replacement device. As a result, testing and assessments have been carried out. Koninklijke Philips N.V., 2004 - 2023. However, as we collect the information that we need to fulfill your order, it will give us the opportunity to review and analyze all patients ready for remediation and determine which will receive their device first. (, Philips Respironics provides update for the US on ongoing CPAP, BiPAP and Mechanical Ventilator field action, Initial testing results suggest that PE-PUR foam degradation in CPAP devices is accelerated by repeated exposure to ozone cleaning. In addition to the prioritization of remediation of those patients at a potentially higher risk, a number of other factors must also be met including sufficient inventory availability and Philips Respironics receipt of necessary information required to transfer existing therapy settings to the replacement unit. Important Note: If a member doesn't want a replacement device through Philips, they should call customer service to find another in-network provider. Updating your device registration with additional demographic and health information does not guarantee that you will receive your device more quickly. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, How to Tell if Your Device Has Been Recalled and What to Do Next, How to Know if You Should Stop Using Your Device, What to Do with Your Device: Cleaners, Filters, Foam, Returns, Philips' Recalls Not Associated with the Foam Issue, How to Report a Health Issue or Problem to the FDA, FDA Safety Communication: Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, How to Locate the Serial Number on your device, report the problem through the FDA's MedWatch Voluntary Reporting Form, Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories, recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam, requested that Philips retain an independent laboratory to perform additional testing of the silicone-based foam, Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices, Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern, Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms, Philips Respironics Recalls V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm, 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, report the problem through the MedWatch Voluntary Reporting Form, Philips' medical device recall information page. Customer Services Portal For Healthcare Professionals Manage the performance and service needs of your healthcare products across modalities, anywhere, anytime Request Access Login to the portal Click here for important information about the recall of certain Philips Respironics Sleep and Respiratory Care devices We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. We are partnering with clinicians and business customers throughout this process to ensure were doing all we can to help you and your healthcare needs. What are my options? 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. Philips Respironics will continue with the remediation program. 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 company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. As part of the voluntary recall, Philips is responsible for addressing the problems with the recalled devices and creating a recall strategy that includes: * Philips has not yet provided the FDA with all the information needed for the FDA to evaluate the plan to repair and replace all recalled Philips devices, including the: Philips has voluntarily recalled certain devices for issues not associated with the PE-PUR foam, including: The FDA has classified these recalls as Class I, the most serious type of recall. Philips generated 2021 sales of EUR 17.2 billion and employs approximately 78,000 employees with sales and services in more than 100 countries. 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. This is a potential risk to health. This is a potential risk to health. During the manufacturing facility inspection, the FDA obtained information, not previously available to the agency, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. The prompts you may see include sharing prescription information or selecting a specific remediation option based on your affected device type. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. How are you removing the old foam safely? Sleep and respiratory care update | Philips 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. 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. Comprehensive particulate testing and analyses for the first-generation DreamStation devices are expected to be completed in the second quarter of 2022. Determining the number of devices in use and in distribution. Philips Respironics is working cooperatively with the US Food and Drug Administration (FDA) to further increase awareness for patients, consumers, and healthcare providers of the recall. Philips is also working cooperatively with the FDA to develop a consolidated summary for healthcare providers on the available, finalized testing data, results, and conclusions, which will be updated as new test data becomes available. I sent in my DreamStation CPAP device and received a DreamStation 2 CPAP Advanced and I would prefer to have my own device back, Philips Respironics Sleep and Respiratory Care devices, Information for patients, all in one place, Learn how to set-up and use your replacement device . Key Resources . *. Please be assured that our teams are working on a comprehensive remediation program to support patients with an affected device. The DME supplier can check to see if your device has been recalled. 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. Koninklijke Philips N.V., 2004 - 2023. While you may have already visited the Patient Portal, its important to regularly visit this site. Dive Brief: Another 40 people may have died after using Philips ventilators, BiPAP machines or CPAP machines included in a recall involving millions of the devices, the Food and Drug Administration said Friday. We understand the profound impact this recall has had on you, and that for those who are waiting for a repaired or replaced device, this progress cant come quickly enough. Selected products For Spanish translation, press 2; Para espaol, oprima 2. ** Philips Respironics has provided the data and analyses to the FDA and other competent authorities. The analysis and conclusion were based on data from a large multicenter cohort study involving 6,900 OSA patients on PAP devices between 2012 and 2020, including 1,200 Philips Respironics PAP users. Providers should encourage patients to register their device through the Philips patient portal at www.philipsrcupdate.expertinquiry.com, or call 1-877-907-7508 to see if the particular device is part of the recall. Philips Respironics continues to monitor recall awareness for affected patients [1]. 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. 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. [1] Philips Respironics monthly surveys indicate that nearly 80% (aggregate data) of responding Philips Respironics CPAP users in the US confirmed they were aware of the recall. 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 did not request a hearing at this time but has stated it will provide a written response. Please be assured that our teams are working on a comprehensive remediation program to support patients with an affected device. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. To register your Philips device or to edit your registration: 877-907-7508 Patient Post remediation Support Hotline: 833-262-1871. Without this information or consent, we cannot ship your replacement device. In some cases, this foam showed signs of degradation (damage) and chemical emissions. Login with your account. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. We strongly recommend that customers and patients do not use ozone-related cleaning products. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. 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 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. In the interim, in specific markets, a Trilogy Evo device can be made available for patients currently using affected Trilogy 100 and 200 devices. With regard to mechanical ventilators, Philips is deploying a permanent corrective action to address the issues described in the recall notification. Medical Device Recall Information - Philips Respironics Sleep and If the Patient Portal shows that your order has been placed, you cannot update your information. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. You are about to visit a Philips global content page, Philips Investor Relations Tel:+31 20 59 77055. Remotely connecting treatment and monitoring devices, Care Orchestrator is a cloud based, home health population management solution treating Sleep Apnea, COPD, and chronic respiratory disorders. The results indicate that the VOC concentrations are within safe exposure limits specified in the applicable safety standard (ISO 18562). Additionally, we remind both 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. 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. Support Portal - Respironics You are about to visit a Philips global content page, 1875 Buckhorn Gate, 5th Floor, Mississauga, Ontario L4W 5P1. Philips Respironics was not involved in the study or the analysis. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. Using alternative treatments for sleep apnea. How does Philips Respironics decide who is sent remediated DreamStation devices? Dutch medical devices maker Philips INPHI said on Tuesday that independent tests have shown that the use of its respiratory devices involved in a major global recall did not cause health risks for patients.. Philips said "rigorous testing" by external parties on the range of DreamStation machines used to treat sleep apnoea showed positive results, confirming preliminary results released last year. Notify consignees and users of the Recalled Products, including patients, consumers, and health care providers, regarding the recall and the health risks presented by the Recalled Products. The FDA has received more than 98,000 complaints about the original Philips recall since April 2021. All rights reserved. Additionally, we remind both 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. 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. 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. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. As a reminder, once you have added your information in the Patient Portal, you cannot change it. 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).