DreamStation 2 Auto CPAP Advanced. Receiving party (contact information):Affiliates other than KoninklijkePhilips N.V.(contact information of responsible division:privacy@philips.com) For any therapy support needs or product questions please reach out hereto find contact information. Philips Respironics received authorization from the U.S. Food and Drug Administration (FDA) to restore affected first-generation DreamStation devices by replacing the PE-PUR sound abatement foam with a new material. Learn About Sleep Apnea and Treatment Options, The Latest CPAP Machine Reviews from Experts, Find the Best CPAP Mask for Your Lifestyle, Our Top Picks to Make CPAP Cleaning a Breeze, Were here to help! 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. Intuitive. 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. One of the more complex aspects of the recall has been creating remediation options for all variations of affected devices. For further information about the Company's collection and use of personal information, please click the URL below. CPAP.com was recently notified by Philips Respironics of a recall for certain CPAP, APAP, and BiPAP devices. How are you removing the old foam safely? 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 . For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. To improve our service quality and deliver up-to-date information and newsletters (text/email) 1. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. If you do not remember your DreamMapper password or need to reset it: Click Forgot your password?. Enter your Username and Password and click Login. 1. 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. With focusing all capacity on the recall, Houten said that approach has a consequence that we will not be able to serve new customers, so theres going to be a shortage in the field.. We thank you for your patience as we work to restore your trust. Questions about registering, signing in or need any otherDreamMapper support? You are about to visit a Philips global content page. 2. After youve registered your machine with Philips and have scheduled an appointment with your sleep care physician to discuss a new treatment plan, you may be wondering if you should keep using your recalled machine and what options exist if you decide its time to purchase a new machine altogether. If you do not have a second device available we suggest you print out the instructions. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Please be assured that our teams are working on a comprehensive remediation program to support patients with an affected device. We may also send messages based on the date you set up your account. Apologize for any inconvenience. View/download instructions for Android devices, View/download instructions for Apple devices, Using an existing account on your mobile device. Your patients may receive a DreamStation 2 as a replacement for their affected CPAP device. Please contact your Philips representative if you are in need of a loaner Trilogy Evo device for a patient. scanning technology for the right mask fit from the start. Your IP address is anonymized prior to use and storage within Apptentive's products and services. We know that you are eager to find out when youll receive your replacement CPAP, BiPAP or Mechanical Ventilator 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. Duration of retention and use of personal information of the receiving parties: Until the purpose of personal information use is achieved If you do not have a second device available we suggest you print out the instructions. 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. You can sign up here. 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. 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). Once set, the device will automatically start at the selected Ramp Plus pressure with all future therapy sessions. You can refuse to provide the Authorization for Collection and Use of Personal Information. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) 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 . At the Login Page for DreamMapper, you can register for a new account or login with your existing Username and Password. Please be assured that our teams are working on a comprehensive remediation program to support patients with an affected device. Download the app Using your mobile device: Download the DreamMapper app by using the app store buttons above. This could affect the prescribed therapy and may void the warranty. 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. If you are a patient who has been affected by this recall, do not try to remove the foam from your device. If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. Can I have it repaired? *Trilogy Evo devices provided as loaners do not contain the silicone foam or the affected PE-PUR foam. As information becomes available, we will update our customers via email and the CPAP community at large using this blog. Enter your Username and affected Device Serial number. Items of Personal Information to be Collected 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. 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. December 2022 update on completed testing for first-generation DreamStation devices . Please be assured that we are treating this matter extremely seriously, and are working to address this issue as efficiently and thoroughly as possible. Philips Korea Corporation (hereinafter the "Company") values your personal information and complies with applicable laws and regulations for personal information protection, including the Personal Information Protection Act. Connect your DreamStation Your DreamStation has built-in support for Bluetooth which will connect to your mobile device and transfer your therapy results. You are about to visit the Philips USA website. 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. Improvement of our service quality for better treatment adherence by using this application How it works. You can also upload your proof of purchase should you need it for any future service or repairs needs. Dont have one? Enter the Captcha characters. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Duration of Retention and Use of Personal Information In the interim, in specific markets, a Trilogy Evo device can be made available for patients currently using affected Trilogy 100 and 200 devices. You can log in or create one. 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. 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. In summary, the CPAP/APAP/BiPAP machine supply was already tight and shrinking before the recall was announced. The information is being updated on a regular basis and answered based on the latest safety communications from the FDA. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. To register your product, youll need to log into your MyPhilips account. 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). Using alternative treatments for sleep apnea. If you had a CPAP machine before you got Medicare, you will need to check with Medicare to see if you qualify for certain requirements that will cover the cost of the replacement of your machine. Why do I need to upload a proof of purchase? 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 . 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. 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. Flurry will not associate your IP address with any other data held by Flurry. IMPORTANT: If a humidifier was included with your sleep therapy device, be sure to remove the water chamber before you proceed. Continuing to use an affected device, if a patients health care provider determines that the benefits outweigh the risks identified in the recall notification. Note: If you are using a mask from another manufacturer, please select Mask Not Listed. If your product is eligible for extended warranty, first you need aMyPhilipsaccount. Since hearing the news we have been in daily communication with Philips Respironics to understand what aid we can provide our customers. 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). 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. Please be assured that we are treating this matter extremely seriously, and are working to address this issue as efficiently and thoroughly as possible. Sharing your sleep therapy data provides them insight on how you are complying with your prescribed sleep therapy regimen. Call1.800.356.5221M-F 8AM-8PM | Sa 8AM-5PM (CST). 2. Fill out the registration form (leave Mobile Phone blank). This is a potential risk to health. You can sign up here. 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. 1. 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. Unlike the DreamStation CPAP device, the DreamStation 2 CPAP Advanced device features the Ramp Plus feature where a user can select a comfortable start pressure. Please visit mydreammapper.com by clicking the Login button above. 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. This process should take about 10 minutes to complete, but may vary based on internet speed or device used. With regard to mechanical ventilators, Philips is deploying a permanent corrective action to address the issues described in the recall notification. If you already have a DreamMapper account but do not remember your Username, please note that your Username is your email address. In that case, we cannot deliver recent information and newsletters, which is available only through collection of personal information. Pricing for CPAP, APAP, and BiPAP machines vary; the average cost of a CPAP machine ranges from $300 to $850, though those with advanced technology features can cost more. If you do not have this letter, please call the number below. Philips Sleep and respiratory care. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. 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 . Enter your Username and affected Device Serial number. This spreadsheet provides Medicare DME fee schedule information, by HCPCS code . 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. You can refuse to provide the Authorization for Collection and Use of Sensitive Information. Philips Respironics will continue with the remediation program. 1875 Buckhorn Gate, 5th Floor, Mississauga, Ontario L4W 5P1. We strongly recommend that customers and patients do not use ozone-related cleaning products. You can find the list of products that are not affected here. Proof of purchase is a printed receipt from the shopwhere you purchased your product, or a PDF invoice from an online retailer. Have the product at hand when registering as you will need to provide the model number. A patient no longer needs to tap a Ramp button every night to start at the desired pressure. Please review the DreamStation 2 Setup and Use video for help on getting started. However, this recall is not a normal circumstance and different insurance companies will have varying courses of action for you to follow. Further testing and analysis is ongoing. 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. Duration of Retention and Use of Personal Information To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation. In some cases, this foam showed signs of degradation (damage) and chemical emissions. To confirm that your Philips PAP device has been recalled, you need to visit the Philips registration site to register your device. Success. If you already have a DreamMapper account but do not remember your Username, please note that your Username is your email address. To register your product, youll need to log in to your My Philips account. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. Philips Respironics issued a voluntary product recall for its breathing devices and ventilators due to sound abatement foam that has a potential to break down. Select country / language; Breathe easier, sleep more naturally . Mandatory items: Time of device use as per the patient's use, prescribed pressure, degree of mask leak, and periodic breathing rate Click Register. Additionally, Philips Respironics suggests patients review the age of their devices, as they are typically recommended to be replaced after five years of use. You are about to visit the Philips USA website. 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. Click Submit to create your account. In the event of exposure to degraded foam: In the event of exposure to chemical emissions: Yes. As a result, testing and assessments have been carried out. Cancel. Philips Respironics Mask Selector uses no-touch. Philips has established a registration process where you can look up your device serial number and begin a claim if your . CPAP.com is a family-owned and operated business dedicated to providing affordable sleep apnea equipment to those who need sleep therapy. After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. Since solutions for the recall are almost as personalized as individual pressure settings themselves, its important to have a discussion with your doctor as soon as possible to determine the next steps. If your product is eligible for extended warranty, first you need aMyPhilipsaccount. My product is not working. By clicking on the link, you will be leaving the official Philips Electronics Ltd. ("Philips") website. Optional item: Mobile phone number Login with your Username and new Password. As new information and options become available to help our customers we will switch our operations accordingly. 5. In that case, your use of the service provided in this application through collection of sensitive information may be restricted. is designed . This recall was announced on June 14, 2021. In that case, your use of the service provided in this application through collection of personal information may be restricted. This means you can set the Ramp Plus presusre once and there is no need to restart it each night. You can still register your device on DreamMapper to view your therapy data. 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. We know that you are eager to find out when youll receive your replacement CPAP, BiPAP or Mechanical Ventilator device. Are there any recall updates regarding patient safety? Doing this could affect the prescribed therapy and may void the warranty. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. 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.. Please be assured that we are doing all we can to resolve the issue as quickly as possible. After youve registered your machine with Philips, you may be asking, what are my options for continuing therapy while I wait for Philips to send me a replacement machine or repair kit? If youre considering purchasing a machine outright and are a long-time user of the DreamStation, we encourage you to check out this article to see how the ResMed AirSense 10 stacks up against the currently-recalled DreamStation from Philips Respironics. For patients using life-sustaining mechanical ventilator devices, they should not stop or change ventilator use until they have talked to their health care providers regarding factors including: Whether in the judgement of the treating clinical team the benefit of continued usage of these ventilator devices may outweigh the potential risks identified in the recall notification. We Asked A Sleep Doctor About The Recent CPAP RecallHeres What He Said, Ultimate How To Guide: Best Ways To Clean Your CPAP, A Complete Review of the Lumin CPAP Mask Cleaner in 2023, ResMed AirSense 10 CPAP Machine Review Updated 2023 Card-to-Cloud Model, A-Series BiPAP Hybrid A30 (not marketed in US). 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. All rights reserved. Our intention is to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. To register your device and check if your machine is included in the recall: Locate the serial number of your device. We recommend you upload your proof of purchase, so you always have it in case you need it. 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. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. First Night Guide. Even Auto ON is enabled so that all you have to do is put your mask on and start breathing. When you refuse to provide the authorization, you may have limited service provided through collection of personal information.