To confirm that your Philips PAP device has been recalled, you need to visit the Philips registration site to register your device. If you already have a DreamMapper account but do not remember your Username, please note that your Username is your email address. This means you can set the Ramp Plus presusre once and there is no need to restart it each night. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. Once the purpose of use is achieved, your personal information will be destroyed immediately, unless otherwise required by laws. Access all your product information in one place (orders, subscriptions, etc. A patient no longer needs to tap a Ramp button every night to start at the desired pressure. What can I do with a My Philips account? on the latest safety communications from the FDA. You can find the list of products that are not affected. Please click either Yes or No. Philips Respironics Mask Selector uses no-touch. Philips Respironics will continue with the remediation program. Flurry will not associate your IP address with any other data held by Flurry. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. For more information about how DreamMapper processes your data click here. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. 2. Success. to help you and your patients succeedtogether. Our experts know CPAP inside and out. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Continuing to use an affected device, if a patients health care provider determines that the benefits outweigh the risks identified in the recall notification. Accept terms and conditions. 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 www.philips.com/SRC-update If you are a patient who has been affected by this recall, do not try to remove the foam from your device. Enter your Username and Password and click Login. Connected. 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. 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. 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. How can I register my product for an extended warranty? 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. 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. If you cant afford a new machine outright or are having issues with your insurance provider, rest assured that there are several options that exist to find low-cost or free CPAP equipment, including government assistance or charity donation programs. Doing this could affect the prescribed therapy and may void the warranty. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. To register your product, youll need to log into your MyPhilips account. You can create one here. Doing this could affect the prescribed therapy and may void the warranty. We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. Select country / language; Breathe easier, sleep more naturally . Our intention is to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. Register your product and enjoy the benefits. 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. Despite sincere and full efforts by members of the Philips Respironics team weve been in contact with, details and actions we can take immediately to have a positive impact on the health of our customers have been in short supply. Give us a call today and one of our 5 star customer service representatives will help you. Select your mask type and specific mask model. Create a new password following the password guidelines. Consultation with health care providers about using an inline bacterial filter with ventilators, which may help to filter out particles of foam, as indicated in the Philips recall notification, which also notes limitations of this option and areas of caution. We understand that any change to your therapy device can feel significant. 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. 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. In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary recall notification. Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. You are about to visit the Philips USA website. Sharing your sleep therapy data provides them insight on how you are complying with your prescribed sleep therapy regimen. Create a new password following the password guidelines. Why do I need to upload a proof of purchase? Using alternative treatments for sleep apnea. For further information about the Company's collection and use of personal information, please click the URL below. We thank you for your patience as we work to restore your trust. Many of the Philips Respironics CPAP, APAP, and BiPAP machines sold from 2009 onward except the DreamStation 2 used this type of sound abatement foam and are impacted by this recall. 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. Please review the DreamStation 2 Setup and Use video for help on getting started. The company announced that it will begin repairing devices this month and has already started . Confirm the new password in the Confirm Password field. You can also upload your proof of purchase, so it is stored safely if you need it for service or repair of your product. Click Save. Duration of Retention and Use of Personal Information
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. This includes Dreamstation, Dreamstation Go, Dreamstation ASV/ST/AVAPS, System One, and Remstar SE Auto . We have completed all requests by Philips Respironics and we eagerly await a plan that will allow us to provide actionable solutions to customers. Receiving party (contact information):Affiliates other than KoninklijkePhilips N.V.(contact information of responsible division:privacy@philips.com)
The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. 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. Your insurance company may: There are some insurance companies who require the use of a Philips-brand machine only, so you will need to speak with a representative of your insurance company directly to determine a solution for repairing or replacing your current device. 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. If you continue using your device, please note that ozone is referenced by Philips Respironics as a potential contributing factor to degraded foam. Register your product and enjoy the benefits. December 2022 update on completed testing for first-generation DreamStation devices, Jan Kimpen, Chief Medical Officer, discusses what the test results mean for healthcare providers and their patients, Jan Bennik, Head of Test and Research Program, explains the details behind the testing results. CPAP.com was recently notified by Philips Respironics of a recall for certain CPAP, APAP, and BiPAP devices. 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. 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 Please note that it is important that you only use approved cleaning methods for our devices and masks, as unapproved cleaning methods such as ozone may contribute to foam degradation. 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. Dont have one? How it works. 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 . Click Save. Questions about registering, signing in or need any otherDreamMapper support? The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) 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. You can refuse to provide the Authorization for Collection and Use of Personal Information. 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.
By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. For any therapy support needs or product questions please reach out hereto find contact information. The DreamStation 2 CPAP Advanced is designed to provide a simplified user experience, including a premium color touchscreen with fewer panes to navigate. Optional item: Mobile phone number
DreamMapper is part of the Dream Family from Philips Respironics. 1. Shop now Item # DSX520H11C Not currently in stock Dreamstation 2 Auto CPAP with Humidifier Overview Per Philips Respironics, possible health risks include exposure to degraded sound abatement foam and exposure to chemical emissions from the foam material.
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. 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. As a first step, if your device is affected, please start the registration process 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. Always follow manufacturer-recommended cleaning instructions. Please contact your Philips representative if you are in need of a loaner Trilogy Evo device for a patient. 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. Additionally, the AASM requests flexibility from CMS in allowing and covering the cost of replacing recalled devices during the five-year reasonable useful lifetime. The letter suggests DME suppliers should be allowed to repair or replace the recalled equipment without the need for a new clinical evaluation or sleep test; requests for patient alleviation from potential repair or replacement costs were suggested, as well. In some cases, this foam showed signs of degradation (damage) and chemical emissions. Register your child's device on the recall website or call (877) 907-7508 for assistance. If your product is eligible for extended warranty, first you need aMyPhilipsaccount. 5. Enter the captcha characters. Further testing and analysis is ongoing. You can still register your device on DreamMapper to view your therapy data. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. 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. Auto CPAP Advanced. 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. 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. Once the purpose of use is achieved, your personal information will be destroyed immediately, unless otherwise required by laws. Why do I need to upload a proof of purchase? Mandatory items: Time of device use as per the patient's use, prescribed pressure, degree of mask leak, and periodic breathing rate
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. 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 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). 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. However, this recall is not a normal circumstance and different insurance companies will have varying courses of action for you to follow. You can. Using a new account on a desktop or laptop. 1. Dont have one? 2. We thank you for your patience as we work to restore your trust. Note: Please use the same email address you used when registering your device for the voluntary recall. 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. 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. Create account Create an account Already have an account? scanning technology for the right mask fit from the start. We strongly recommend that customers and patients do not use ozone-related cleaning products. Acknowledge all consents. Since the news broke, customers have let us know they are frustrated and concerned. *Trilogy Evo devices provided as loaners do not contain the silicone foam or the affected PE-PUR foam. You are about to visit the Philips USA website. (, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. Duration of retention and use of personal information of the receiving parties: Until the purpose of personal information use is achieved
Philips Respironics guidance for healthcare providers and patients remains unchanged. 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. Receiving party's purpose of use of personal information: Store the collected information
2. 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 is designed . DreamStation 2 Auto CPAP Advanced. Products that are not affected may have different sound abatement foam material, as new materials and technologies have become available over time. Apologize for any inconvenience. Selected products Please visit mydreammapper.com by clicking the Login button above. 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 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. Many dealers expect to run out and go through at least intermittent back order periods for the foreseeable future. The CPAP team strives to provide insightful and meaningful information to its audience, keeping you in the know on the latest happenings in the sleep health and respiratory world. This means you can set the Ramp Plus presusre once and there is no need to restart it each night. Our update in November 2021 provides broadened guidance regarding affected CPAP, BiLevel PAP and Mechanical Ventilator devices, and mechanical ventilators, as follows: For patients using BiLevel PAP and CPAP devices, talk to a health care provider to decide on a suitable treatment for medical conditions, which may include: Using another similar device that is not part of the recall. Call1.800.356.5221M-F 8AM-8PM | Sa 8AM-5PM (CST). What devices have you already begun to repair/replace? In the interim, in specific markets, a Trilogy Evo device can be made available for patients currently using affected Trilogy 100 and 200 devices. Philips Respironics DreamStation 2 Auto CPAP Advanced with Humidifier BY Philips Respironics Item #DSX520H11C $1205.00 5 Reviews QTY 1 Out of Stock Prescription required Free Shipping Need replacement parts and accessories? 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. We agree. 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. Last year the FDA issued a safety communication about PAP cleaners. 1. It also will guide you through the registration process. 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 has established a registration process where you can look up your device serial number and begin a claim if your . To improve our service quality and deliver up-to-date information and newsletters (text/email)
3. If you have not done so already, please click here to begin the device registration process. Agree
Dont have one? Those risks include but are not limited to headaches, nausea, irritation of the eyes, nose or skin or potential cancer . 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. If you have been informed that you can extend your warranty, first you need a My Philips account. You are about to visit a Philips global content page. ** Philips Respironics has provided the data and analyses to the FDA and other competent authorities. Once Philips Respironics has confirmed payment details and your acceptance of the estimate our service department will complete the repair or service and return the device to the shipping address you provide on the "Request for Service" form. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) You may have a high deductible or perhaps you have preferences for a specific vendor that isnt covered under your current policy. 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 do not have a second device available we suggest you print out the instructions. 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. Using alternative treatments for sleep apnea. We understand that any change to your therapy device can feel significant. If you do not remember your DreamMapper password or need to reset it: Click Forgot your password?. Don't have one? 6. Fill out the registration form (leave Mobile Phone blank). 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. All rights reserved.
We know that you are eager to find out when youll receive your replacement CPAP, BiPAP or Mechanical Ventilator device. Your individual coverage with Medicare or Medicaid will determine how to proceed with your device. Please open the DreamMapper app on your mobile device and enter your Username and Password and click Login. If you do not have a second device available we suggest you print out the instructions. This spreadsheet provides Medicare DME fee schedule information, by HCPCS code . 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Koninklijke Philips N.V., 2004 - 2023. This could affect the prescribed therapy and may void the warranty. 1875 Buckhorn Gate, 5th Floor, Mississauga, Ontario L4W 5P1. You can still register your device on DreamMapper to view your therapy data. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. 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. 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. You can create one here. To improve treatment adherence by analyzing information of patient's CPAP use and delivering the analysis results to the patient
Product Support: 800-685-2999. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to register your CPAP machine / BIPAP machine/mechanical ventilator devices for the Philips Respironics Recall. This is not our choice or our preference. With regard to mechanical ventilators, Philips is deploying a permanent corrective action to address the issues described in the recall notification. 1. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. Optional items: Email address and mobile phone number