Amsterdam, the Netherlands - Following the company update on April 26, 2021, Royal Philips (NYSE: PHG; AEX: PHIA) today provides an update on the recall notification* for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address identified . If your product is eligible for extended warranty, first you need aMyPhilipsaccount. Apologize for any inconvenience. On behalf of Philips, Flurry will use this information for the evaluation of your use of the App, compiling reports on App activity for Philips, and in order to provide other services relating to App activity and use of the App to Philips. Not all direct-to-consumer brands offer sales and discounts, though. As mentioned, receiving a new device through your insurance plan requires a new prescription from your physician with documentation stating that you are using and benefitting from your sleep apnea treatment. The Food and Drug Administration (FDA) has authorized Philips to start repairing the first-generation DreamStation sleep apnea machines that were recalled in June because foam used in the devices posed health issues to consumers. We recommend you upload your proof of purchase, so you always have it in case you need it. Dont have one? You are about to visit a Philips global content page. 1. I O By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. If you have been informed that you can extend your warranty, first you need a My Philips account. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. This means you can set the Ramp Plus presusre once and there is no need to restart it each night. To register your device and check if your machine is included in the recall: Philips Respironics plans to replace the current sound abatement foam with a new material that is not affected by this issue. First Night Guide. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. This recall notification/field safety notice has not yet been classified by regulatory agencies. Periodically, DreamMapper data is analyzed to determine where improvements can be made to the application and to determine the frequency that functions within the application is used. Login with your Username and new Password. 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). With regard to mechanical ventilators, Philips is deploying a permanent corrective action to address the issues described in the recall notification. Youcan also upload your proof of purchase, so it is stored safely if you need it for service or repair of your product. You will be using Bluetooth to transfer your therapy results to the DreamMapper app. ** Philips Respironics has provided the data and analyses to the FDA and other competent authorities. At the Login Page for DreamMapper, you can register for a new account or login with your existing Username and Password. You can create one here. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. To register your product, youll need to log into your MyPhilips account. Per Philips Respironics CEO Frans van Houten We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety.. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Even Auto ON is enabled so that all you have to do is put your mask on and start breathing. You are about to visit the Philips USA website. DreamMapper has the ability to share your therapy data with your Home Care Providers electronic health records system. We have notified all customers affected by the recall through email and each customer will shortly receive a physical mailed notice. Following two rounds of comprehensive customer and patient outreach, Philips Respironics has reached the vast majority of the installed base in the US resulting in the registration of approximately 2.6 million devices in the country. You can still file a claim for reimbursement, but keep in mind that reimbursement is fully dependent on your insurance provider. Please click either Yes or No. 6. We understand that any change to your therapy device can feel significant. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone, and high heat and high humidity environments may also contribute to foam degradation.. To register a new purchase, please have the product at hand and log into your MyPhilips account. Philips Respironics has provided the relevant regulatory agencies with required information related to the launch and implementation of the projected correction and contracted with a third-party vendor to coordinate the recall effort. You can sign up here. You can still register your device on DreamMapper to view your therapy data. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Have the product at hand when registering as you will need to provide the model number. Philips Respironics Chief Executive Frans van Houten said, Were going to put all our capacity to focus entirely on replacing and repairing these units, a process he said would likely take a year. December 2022 update on completed testing for first-generation DreamStation devices . U.S. only: If you are looking for more information on how to use your new device and become familiar with it, you can visit www.philips.com/ds2-replacement for more information. Enter your Username and affected Device Serial number. If you have any concerns we suggest you contact your durable medical equipment provider or your sleep specialist.Per Philips Respironics, all patients using one of their PAP devices should discontinue use immediately due to the health risks. Register the device on the recall website www.philips.com/src-updates The website provides current information on the status of the recall and how to receive permanent corrective action to. to help you and your patients succeedtogether. Approve a rental device of the same caliber and quality as your original equipment, Determine that the recall voids the standard replacement requirement and immediately replace the device, Deny covering the cost of a new machine at this time. Click Return to Login after successful password reset. 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. 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). The DreamStation 2 CPAP Advanced is designed to provide a simplified user experience, including a premium color touchscreen with fewer panes to navigate. Koninklijke Philips N.V., 2004 - 2023. Our experts know CPAP inside and out. What information do I need to provide to register a product? In some cases, this foam showed signs of degradation (damage) and chemical emissions. 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. When you provide the authorization for collection and use of personal information below, you will be informed of various information about recent news and events via text message or email. Philips Respironics DreamStation CPAP Machine: Two-years limited warranty DeVilbiss IntelliPAP Standard CPAP Machine: Five-year warranty Somnetics Transcend EZEX miniCPAP Machine: Three-year warranty Manufacturer warranties actually begin on the day you buy the CPAP machine from the manufacturer. In that case, your use of the service provided in this application through collection of personal information may be restricted. 2. We will continue to take any actions Philips Respironics or the organizations governing them approve relating to this recall as quickly as we are able to execute them. When you provide the Authorization for Collection and Use of Personal Information below, you can use services for improved enhance treatment adherence through this application. unapproved cleaning methods such as ozone may contribute to foam degradation. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. is designed . We are advocating on your behalf to get quicker updates and more information about the situation as it evolves.
We have developed a comprehensive plan to replace the current sound abatement foam with a new material that is not affected by this issue and have already begun this process. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. If you do not remember your DreamMapper password or need to reset it: Click Forgot Password?. By design. To register your product, youll need to log into your MyPhilips account. As a result, testing and assessments have been carried out. The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. We recently spoke with Dr. Daniel Barone, an Attending Neurologist at New York Presbyterian/Weill Cornell Medical Center, to address some of the questions you may have about the recall and the impact it has on your sleep apnea treatment. Agree
We know that you are eager to find out when youll receive your replacement CPAP, BiPAP or Mechanical Ventilator device. The Dream Family offers innovative, comprehensive sleep therapy technology like: . Confirm the new password in the Confirm Password field. DreamMapper data is also analyzed to determine the number of patients that are using DreamStation related products as well as other Philips products. With regard to mechanical ventilators, Philips is deploying a permanent corrective action to address the issues described in the recall notification. 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. Cancel. 2. Call1.800.356.5221M-F 8AM-8PM | Sa 8AM-5PM (CST). Don't have one? We are happy to review your prescription if youre unsure of its status. 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. 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 . 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. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. Dont have one? Register your device (s) on Philips' recall website . Please open the DreamMapper app on your mobile device and enter your Username and Password and click Login. Amsterdam, the Netherlands - Royal Philips (NYSE: PHG; AEX: PHIA) today provides an update on the comprehensive test and research program of its subsidiary Philips Respironics, following the voluntary recall notification/field safety notice* to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in specific CPAP, BiPAP and mechanical . With Philips Respironics focusing on the recall, the U.S. CPAP/APAP/BiPAP supply was cut in half overnight. Note: Please use the same email address you used when registering your device for the voluntary recall. We created this helpful guide to finding a low-cost CPAP machine if you cant afford to purchase a new machine. We will continue daily checks with the Philips Respironics team to ensure we are executing everything possible to help our customers through this recall. By clicking on the link, you will be leaving the official Philips Electronics Ltd. ("Philips") website. Your patients may receive a DreamStation 2 as a replacement for their affected CPAP device. We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. Register your device on the Philips recall website or call 1-877-907-7508. This approach needs to go through some regulatory hurdles first. You may have a high deductible or perhaps you have preferences for a specific vendor that isnt covered under your current policy. Please be assured that our teams are working on a comprehensive remediation program to support patients with an affected device. You can sign up here. 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. Please be assured that we are doing all we can to resolve the issue as quickly as possible. For us to send you a replacement device, we will first need to get your prescription settings from your current device and then we will load those into your replacement device. Selected products While the CPAP recall is a frustrating experience, it does serve as an opportunity to switch up your CPAP equipment set-up so you can find the device that serves your needs best. 1. Below youll find a list of commonly asked questions about the CPAP recall. To do this you will need to register for a DreamMapper account or sign into your existing account using either the DreamMapper app on your moble device or via the DreamMapper website on your desktop or laptop computer. Please click either Yes or No. One of the more complex aspects of the recall has been creating remediation options for all variations of affected devices. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Youcan also upload your proof of purchase, so it is stored safely if you need it for service or repair of your product. To register your product, you'll need to log into your MyPhilips account. Amsterdam, the Netherlands - In June 2021, Royal Philips' (NYSE: PHG, AEX: PHIA) subsidiary, Philips Respironics, initiated a voluntary recall notification in the US/field safety notice in other countries for certain sleep and respiratory care products to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in certain CPAP, BiPAP and .