Simplified. Please note that once an RP kit is shipped for the affected Trilogy 100/200 device, the loaner Trilogy Evo must be returned within 45 days to avoid being charged. For more information about how DreamMapper processes your data click here. With regard to mechanical ventilators, Philips is deploying a permanent corrective action to address the issues described in the recall notification. Fill out the registration form (leave Mobile Phone blank). Each day more information becomes available. With Philips Respironics focusing on the recall, the U.S. CPAP/APAP/BiPAP supply was cut in half overnight. Enter your Username and affected Device Serial number. We will continue to provide regular updates to you through monthly emails. Register your device on the Philips recall website or call 1-877-907-7508. Register your device (s) on Philips Respironics' recall website to stay informed of updates from Philips Respironics regarding any new instructions or other corrective fixes, which the. As a reminder, we recommend using a second device to read through the step-by-step instructions for an easier set up and transfer process. This process should take about 10 minutes to complete, but may vary based on internet speed or device used. To register your product, youll need to log in to your My Philips account. The serial number is located on the bottom of your device and it begins with "P" or "J" and contains 13 characters or begins with "D" and contains 14 characters. Please review the attached. We may also send messages based on the date you set up your account. 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). By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Intuitive. How can I register my product for an extended warranty? Register - Philips Respironics DreamMapper Register Country* First Name Last Name Email Address* Confirm Email Address* Mobile Phone Primary Device Serial Number I understand and accept the Terms and Conditions. Last year the FDA issued a safety communication about PAP cleaners. to help you and your patients succeedtogether. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 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. As a first step, if your device is affected, please start the. Please read carefully and fully understand all terms of "Service Agreement" and "Privacy Policy", including but not limited to: to provide you with services of your usage of the device, we need to collect personal information like information about your device,operation log, etc.. You can view, change, delete personal information and manage your authorization at "Settings". 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. Register your child's device on the recall website or call (877) 907-7508 for assistance. You can log in or create one. 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. DreamMapper is part of the Dream Family from Philips Respironics. Register your product and start enjoying benefits right away. Click Register. 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. Click Save. As information becomes available, we will update our customers via email and the CPAP community at large using this blog. 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. To register your product, youll need to. 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. If you do not remember your DreamMapper password or need to reset it: Click Forgot Password?. Dreammapper has the ability to send you in app notifications based on inputs you provide directly when you set up your account, such as what mask you use, in addition to promotional messaging from Philips. Philips Respironics continues to monitor recall awareness for affected patients [1]. Dont have one? Can I trust the new foam? Please note that once an RP kit is shipped for the affected Trilogy 100/200 device, the loaner Trilogy Evo must be returned within 45 days to avoid being charged. Products that are not affected may have different sound abatement foam material, as new materials and technologies have become available over time. 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. On June 14, 2021, Royal Philips' subsidiary, Philips Respironics, initiated a voluntary recall notification * for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. We understand that any change to your therapy device can feel significant. Click Next. All rights reserved. We will continue daily checks with the Philips Respironics team to ensure we are executing everything possible to help our customers through this recall. Receiving party (contact information):Affiliates other than KoninklijkePhilips N.V.(contact information of responsible division:privacy@philips.com) These issues may result in serious injury that can cause permanent impairment or even be life-threatening. Once the purpose of use is achieved, your sensitive information will be destroyed immediately, unless otherwise required by laws. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. Philips Respironics is initiating its repair and replacement program in other countries and expects the program to be underway in most markets by the end of September 2021. Not all details of this recall are known at this time. You are about to visit a Philips global content page. In order to unlock DreamMappers full capabilities you will need to provide the Device Serial number that is on your Philips Sleep Therapy Device. To register your product, youll need to log in to your My Philips account. 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. You will be using Bluetooth to transfer your therapy results to the DreamMapper app. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. 5. Don't have one? Further testing and analysis is ongoing. This is a potential risk to health. Questions about next steps after you have transferred your prescription settings? Create a new password following the password guidelines. This recall notification/field safety notice has not yet been classified by regulatory agencies. In that case, your use of the service provided in this application through collection of personal information may be restricted. Why do I need to upload a proof of purchase? Doing this could affect the prescribed therapy and may void the warranty. Enter your Username and Password and click Login. The recall effects millions of units and replacement isn't coming for a long. 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. Further testing and analysis is ongoing. You can. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). If you are a patient who has been affected by this recall, do not try to remove the foam from your device. What can I do with a My Philips account? Those who have Medicare are in a similar case-by-case situation. Login with your Username and new Password. There are currently no items in your shopping cart. Why do I need to upload a proof of purchase? We strongly recommend that customers and patients do not use ozone-related cleaning products. IMPORTANT: If a humidifier was included with your sleep therapy device, be sure to remove the water chamber before you proceed. If your product is eligible for extended warranty, first you need aMyPhilipsaccount. We encourage you to read it if youre experiencing hardship during this recall. We are absolutely committed to supporting the worldwide community of patients who rely on our Sleep & Respiratory Care solutions for their health and quality of life, and the physicians and customers who are dedicated to meeting patient needs., Philips Respironics identified there is risk the PE-SUR sound abatement foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals. Please know that your health and safety is our main priority, as we work through this process. Please review the DreamStation 2 Setup and Use video for help on getting started. 1. 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 Sleep and respiratory care. Log in As we learn more, we will update our customers via email and the CPAP community at large using this blog. This process should take about 10 minutes to complete, but may vary based on internet speed or device used. If you do not have this letter, please call the number below. If you allow us to use this information for marketing purposes, we may send you marketing messages based on your device model. Shop now Item # DSX520H11C Not currently in stock Dreamstation 2 Auto CPAP with Humidifier Overview Once you have successfully logged in, please select your mobile device operating system below for specific instructions on how to transfer the data from your current device to DreamMapper. Philips Respironics offers innovative products for sleep and home respiratory care as well as medical education and value-added programs to help you navigate a rapidly changing industry landscape, and in the interest of maximizing both clinical and business success. First Night Guide. For those who cannot currently afford new equipment but who have been encouraged to continue their sleep apnea treatment, weve included a few solutions at the end of this article that we hope can be beneficial to you. If you continue using your device, please note that ozone is referenced by Philips Respironics as a potential contributing factor to degraded foam. 1. A patient no longer needs to tap a Ramp button every night to start at the desired pressure. You can log in or create one. Purpose of Collection and Use of Sensitive Information After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models Sound Abatement Foam Susceptibility to Degradation and Volatile Organic Compound Emission Dear Device Customer, Philips Respironics is voluntarily recalling the below devices due to two (2) issues related to the Product Support: 541-598-3800. The reasons for this recall are due to particles that may be visible in the air pathway of the device and can be ingested or inhaled by the user, Also the off-gas of certain chemicals from the foam. Apologize for any inconvenience. Selected products 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. 2. All oxygen concentrators, respiratory drug delivery products, airway clearance products. If you do not have a second device available we suggest you print out the instructions. Authorization for Disclosure of Personal Information to a Third Party, I agree for my personal data to be processed in the DreamMapper App for creating my account and user profile and to provide a view of usage of my therapy device (s) to assist me with complying with my sleep therapy goals. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. Login with your Username and new Password. This could affect the prescribed therapy and may void the warranty. Your individual coverage with Medicare or Medicaid will determine how to proceed with your device. Even Auto ON is enabled so that all you have to do is put your mask on and start breathing. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. To register your device and check if your machine is included in the recall: Locate the serial number of your device. You can still register your device on DreamMapper to view your therapy data. Countries where the receiving parties are located:Japan, Europe, etc. Bluetooth pairing and data transfer Once you have created your account, please select your mobile device operating system below for specific instructions on how to transfer the data from your current device to DreamMapper. Once the purpose of use is achieved, your personal information will be destroyed immediately, unless otherwise required by laws. Auto CPAP Advanced. We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. Product Support: 800-685-2999. Don't have one? By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. We recommend you upload your proof of purchase, so you always have it in case you need it. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Please contact your Philips representative if you are in need of a loaner Trilogy Evo device for a patient. In that case, we cannot deliver recent information and newsletters, which is available only through collection of personal information. 2. 2. What information do I need to provide to register a product? At the Login Page for DreamMapper, you can register for a new account or login with your existing Username and Password. 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 . According to an CPAP machine FDA recall notice issued on June 30, 2021, the following Philips Respironics sleep apnea and breathing devices sold between 2009 and April 2021 may pose serious health risks: CPAP and BiPAP Device Recalls Non-Continuous ventilators: DreamStation DreamStation Go Dorma 400 Dorma 500 REMstar SE Auto Download the app Using your mobile device: Download the DreamMapper app by using the app store buttons above. During the registration process, Philips Respironics will either let you know your machine is not included in the recall or provide you with a confirmation number. To register your product, youll need to log into your MyPhilips account. 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. Accept terms and conditions. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Then you can register your product. Flurry will not associate your IP address with any other data held by Flurry. The DreamStation 2 CPAP Advanced is designed to provide a simplified user experience, including a premium color touchscreen with fewer panes to navigate. Items of personal information provided: Country, name, email address, device serial number, and telephone number On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. Per Philips Respironics, possible health risks include exposure to degraded sound abatement foam and exposure to chemical emissions from the foam material. 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. Please be assured that we are treating this matter extremely seriously, and are working to address this issue as efficiently and thoroughly as possible. If you do not have a second device available we suggest you print out the instructions. Please be assured that our teams are working on a comprehensive remediation program to support patients with an affected device. 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. 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. We will continue to provide regular updates to you through monthly emails. Please visit mydreammapper.com by clicking the Login button above. Koninklijke Philips N.V., 2004 - 2023. We know that you are eager to find out when youll receive your replacement CPAP, BiPAP or Mechanical Ventilator device. In the interim, in specific markets, a Trilogy Evo device can be made available for patients currently using affected Trilogy 100 and 200 devices. We thank you for your patience as we work to restore your trust. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. You are about to visit the Philips USA website. Flurry Analytics uses cookies or similar techniques, which are text files placed in your App, in order to help the App to analyze overall traffic patterns through our App. The risks include that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone.Product DescriptionThe Philips Respironics . Youcan also upload your proof of purchase, so it is stored safely if you need it for service or repair of your product. This recall was announced on June 14, 2021. You can change your settings any time if you prefer not to receive these communications. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. COPYRIGHT 19992021 US EXPEDITERS, INC. ALL RIGHTS RESERVED. We have completed all requests by Philips Respironics and we eagerly await a plan that will allow us to provide actionable solutions to customers. Have your DreamStation device serial number available (begins with the letter J and is 13 characters in length). Create a new password following the password guidelines. Please contact your Philips representative if you are in need of a loaner Trilogy Evo device for a patient. If you already have a DreamMapper account but do not remember your Username, please note that your Username is your email address. You can sign up here. Purpose of Collection and Use of Personal Information The recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). For further information about the Company's collection and use of personal information, please click the URL below. Philips Respironics will continue with the remediation program. 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. 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. As new information and options become available to help our customers we will switch our operations accordingly. Please click either Yes or No. Philips has established a registration process where you can look up your device serial number and begin a claim if your . Since hearing the news we have been in daily communication with Philips Respironics to understand what aid we can provide our customers. Even Auto ON is enabled so that all you have to do is put your mask on and start breathing. Heres How to Get Low-Cost or Free CPAP Supplies! Sharing your sleep therapy data provides them insight on how you are complying with your prescribed sleep therapy regimen. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. Proof of purchase may be required to take advantage of a promotion or request a repair within warranty. If you are using a mobile device to transfer your data, we recommend using a second device to read through the step-by-step instructions for an easier set up and transfer process. If you do not remember your DreamMapper password or need to reset it: Click Forgot your password?. This is a potential risk to health. The advocacy demonstrated by the AASM has not been confirmed as a solution from CMS, however, so the best course of action is to call your Medicare or Medicaid provider directly regarding new sleep studies, reimbursement for repair costs, or the issuance of a new device. First Night Guide. Philips Respironics received authorization from the U.S. Food and Drug Administration (FDA) to replace the PE-PUR sound abatement foam with a new material, and the company anticipates the rework to begin this month for affected first-generation DreamStation devices in the United States. No matter what type of health insurance coverage you have, you should call your health insurance group soon to see which steps you need to take once youve registered your device and spoken with your doctor. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. I O 1. 2. This App uses Flurry Analytics, an analytics service (Flurry Analytics) provided by Yahoo Inc. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. 2. The company intends to complete its repair and replacement programs within approximately 12 months. If your prescription has expired, its worth considering a home sleep testwhich lets you complete a sleep study from the comfort of your own bedto renew your prescription. Please be assured that we are treating this matter extremely seriously, and are working to address this issue as efficiently and thoroughly as possible. 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.