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. We have completed all requests by Philips Respironics and we eagerly await a plan that will allow us to provide actionable solutions to customers. 3. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Additionally, Philips Respironics suggests patients review the age of their devices, as they are typically recommended to be replaced after five years of use. Koninklijke Philips N.V., 2004 - 2023. 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. On behalf of Philips, Apptentive will use information about your device (such as manufacturer, model, and operating system), app usage patterns, and information you elect to provide (such as survey responses or feedback) to provide services to Philips to help them understand App usage, provide support, and improve their products and services. 2.
For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Acknowledge all consents. This includes Dreamstation, Dreamstation Go, Dreamstation ASV/ST/AVAPS, System One, and Remstar SE Auto . Click Next. If you do not have a second device available we suggest you print out the instructions. As a result, testing and assessments have been carried out. Further testing and analysis is ongoing. The devices included are CPAP machines due to issues related to the polyester-based polyurethane sound abatement foam used in its continuous and non-continuous ventilators. Not all direct-to-consumer brands offer sales and discounts, though. 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.. 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. Dont have one? Per Philips Respironics, possible health risks include exposure to degraded sound abatement foam and exposure to chemical emissions from the foam material. If you do not have a second device available we suggest you print out the instructions. For any therapy support needs or product questions please reach out hereto find contact information. Please be assured that our teams are working on a comprehensive remediation program to support patients with an affected device. The data shared includes your usage of the device, mask leak measurements, CPAP pressure and your periodic breathing rate. 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. The website will give you instructions on how to locate the serial number of your device. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. Philips Respironics Mask Selector uses no-touch. We know that you are eager to find out when youll receive your replacement CPAP, BiPAP or Mechanical Ventilator device. 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. To register your product, you'll need to log into you're my Philips account. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. At the Login Page for DreamMapper, you can register for a new account or login with your existing Username and Password. Please visit mydreammapper.com by clicking the Login button above. Optional items: Email address and mobile phone number
Enter your Username and affected Device Serial number. We are advocating on your behalf to get quicker updates and more information about the situation as it evolves. 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. 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. 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 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. Login with your Username and new Password. 1. 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). 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.
Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. To register a product you need: MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). We have notified all customers affected by the recall through email and each customer will shortly receive a physical mailed notice. This is a potential risk to health. Don't have one? 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. 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. What is the safety issue with the device? This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. 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. Have your DreamStation device serial number available (begins with the letter J and is 13 characters in length). Confirm the new password in the Confirm Password field. Please be assured that we are treating this matter extremely seriously, and are working to address this issue as efficiently and thoroughly as possible. Don't have one? 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. In many cases when a product doesnt perform as you would expect, the problem can be resolved at home through basic troubleshooting. 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. 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. Access all your product information in one place (orders, subscriptions, etc. How can I register my product for an extended warranty? The company anticipates the rework to begin this month. Whether you choose to buy a machine outright or through your insurance company or pursue options through a government assistance program or donation initiative, CPAP.com is here to help you navigate the CPAP recall. 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 . Here is the American Association of Sleep Medicines guidance to sleep physicians and their guidance to patients regarding the recall. Please check our online troubleshooting and FAQs to find solutions for the most common issues, Kindly contact with our consumer support team by the following this link. Youcan also upload your proof of purchase, so it is stored safely if you need it for service or repair of your product. CPAP.com was recently notified by Philips Respironics of a recall for certain CPAP, APAP, and BiPAP devices. Click Next. Note: Please use the same email address you used when registering your device for the voluntary recall. View/download instructions for desktop and laptop, Using an existing account on a desktop or laptop. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. Koninklijke Philips N.V., 2004 - 2023. This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation. You are about to visit the Philips USA website. Selected products To register your product, you'll need to log into your MyPhilips account. . Duration of Retention and Use of Sensitive Information
Not all details of this recall are known at this time. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Give us a call today and one of our 5 star customer service representatives will help you. Why do I need to upload a proof of purchase? In this video, we will be going into detail about the process to register your device on the Philips website. Confirm the new password in the Confirm Password field. Duration of Retention and Use of Personal Information
You can also upload your proof of purchase, so it is stored safely if you need it for service or repair of your product. Apologize for any inconvenience. 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. 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. 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. Each day more information becomes available. 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. 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. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . What information do I need to provide to register a product? Accept terms and conditions. How are you removing the old foam safely? Many dealers expect to run out and go through at least intermittent back order periods for the foreseeable future. is designed . With regard to mechanical ventilators, Philips is deploying a permanent corrective action to address the issues described in the recall notification. 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. Receiving party (contact information):Affiliates other than KoninklijkePhilips N.V.(contact information of responsible division:privacy@philips.com)
All rights reserved. This could affect the prescribed therapy and may void the warranty. In the article, Dr. Barone discusses the risks of abruptly ending treatment versus using a recalled device. 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. 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. 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. Agree
By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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 App uses Flurry Analytics, an analytics service (Flurry Analytics) provided by Yahoo Inc. 2. Register your device on the Philips recall website or call 1-877-907-7508. 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. Have the product at hand when registering as you will need to provide the model number. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. The company intends to complete its repair and replacement programs within approximately 12 months. 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 create one here. This is a potential risk to health. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. We encourage you to read it if youre experiencing hardship during this recall. Confirm the new password in the Confirm Password field. COPYRIGHT 19992021 US EXPEDITERS, INC. ALL RIGHTS RESERVED. Latest Update Regarding Philips Effort To Repair and Replace DreamStation Devices: On September 1, 2021 Philips Respironics issued a statement informing United States-based customers of its new repair and replacement program for first-generation DreamStation devices in relation to the June 14, 2021 recall notification. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. 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. Keep in mind that the CPAP recall is an ongoing situation, so information from your health insurance provider or Medicare may change. 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? 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. FAQ 1. Fill out the registration form (leave Mobile Phone blank). View/download instructions for Android devices, View/download instructions for Apple devices, Using an existing account on your mobile device. Auto CPAP Advanced. We recommend you upload your proof of purchase, so you always have it in case you need it. To improve our service quality and deliver up-to-date information and newsletters (text/email)
Philips has established a registration process where you can look up your device serial number and begin a claim if your . Youcan also upload your proof of purchase, so it is stored safely if you need it for service or repair of your product. Information for Philips Respironics DreamStation users, How to transfer prescription settings from youraffected device so Philips Respironics can begin to prepare your replacement device, Using a new account on your mobile device. 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.. Click Submit to create your account. In that case, your use of the service provided in this application through collection of personal information may be restricted. to help you and your patients succeedtogether. 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. Next
Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. You can log in or create one here. This process should take about 10 minutes to complete, but may vary based on internet speed or device used. Further testing and analysis is ongoing. You can. Once the purpose of use is achieved, your personal information will be destroyed immediately, unless otherwise required by laws. 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 . 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. 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. 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. 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. With Philips Respironics focusing on the recall, the U.S. CPAP/APAP/BiPAP supply was cut in half overnight. Register your product and start enjoying benefits right away. Register your product and enjoy the benefits. We know how important it is to feel confident that your therapy device is safe to use. 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. 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: Stopping use of an affected device Using another similar device that is not part of the recall Continuing to use an affected device, if a patients health care provider determines that the benefits outweigh the risks identified in the recall notification. 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. Last year the FDA issued a safety communication about PAP cleaners. All rights reserved. Why do I need to upload a proof of purchase? Duration of Retention and Use of Personal Information
For patients with an Android (Android version 7 or higher required) or Apple (iOS version 10 or higher required) mobile device, please download the DreamMapper mobile app from your respective app store. Using alternative treatments for sleep apnea. A patient no longer needs to tap a Ramp button every night to start at the desired pressure. The Company may provide a part or all of your personal information to a third party to facilitate the work. 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. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. If you do not have a second device available we suggest you print out the instructions. All of the relationships we hold dear, our family, friends, coworkers, and customers are affected. You can sign up here. Learn more about the full recall process here. We will continue to provide regular updates to you through monthly emails. Philips Respironics DreamStation AutoSVPlease Note: Philips has stated there are possible risks to users related to the sound abatement foam used in certain Philip's sleep devices currently in use.