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. Luna 2 CPAP Review: How Does It Compare to the DreamStation? Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices Sign in now New to My Philips? Philips Respironics Sleep Apnea Care Please open the DreamMapper app on your mobile device and enter your Username and Password and click Login. Dont have one? Information for Philips Respironics DreamStation users SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. 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.. To register your product, youll need to log into your MyPhilips account. 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 . Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. We also offer frequent discounts on our machines, masks, and other CPAP accessories, which can help you save money on the equipment you need. 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. Philips Sleep and Respiratory Care Devices - Australia and New Zealand Register your device On April 26, 2021, Philips globally provided an important update to the market regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio. You should have received a letter from Philips about this issue that contains log-in credentials for the registration website. This means you can set the Ramp Plus presusre once and there is no need to restart it each night. In many cases when a product doesnt perform as you would expect, the problem can be resolved at home through basic troubleshooting. Here is the American Association of Sleep Medicines guidance to sleep physicians and their guidance to patients regarding the recall. If the product does not perform after following the FAQs & troubleshooting steps. To register your product, youll need to log in to your My Philips account. Questions about registering, signing in or need any otherDreamMapper support? Per Philips Respironics, possible health risks include exposure to degraded sound abatement foam and exposure to chemical emissions from the foam material. Once set, the device will automatically start at the selected Ramp Plus pressure with all future therapy sessions. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. 2. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. Duration of Retention and Use of Personal Information 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 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 will continue to provide regular updates to you through monthly emails. 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. Even Auto ON is enabled so that all you have to do is put your mask on and start breathing. Product Support: 800-685-2999. 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.. Proof of purchase may be required to take advantage of a promotion or request a repair within warranty. Philips Respironics guidance for healthcare providers and patients remains unchanged. scanning technology for the right mask fit from the start. Access all your product information in one place (orders, subscriptions, etc. We know how important it is to feel confident that your therapy device is safe to use. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. First Night Guide. We encourage you to read it if youre experiencing hardship during this recall. 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 . Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Amsterdam, the Netherlands - In June 2021, Royal Philips' (NYSE: PHG, AEX: PHIA) subsidiary, Philips Respironics, initiated a voluntary recall notification in the US/field safety notice in other countries for certain sleep and respiratory care products to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in certain CPAP, BiPAP and . You can prevent Flurrys and Philips' collection and use of data (cookies and IP address) if you opt-out after you close this screen. 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. Philips reports that, "The potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects." Philips reports that the foam-related complaint rate in 2020 was low (0.03%). 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. 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.. Proof of purchase may be required to take advantage of a promotion or request a repair within warranty. 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. As we learn more, we will update our customers via email and the CPAP community at large using this blog. To register a product you need: MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. 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. Additionally, Philips Respironics suggests patients review the age of their devices, as they are typically recommended to be replaced after five years of use. 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. This video shows how the patient (device user) can check if their Philips Sleep and Respiratory Care medical device is affected by the recall and if so, how . You will be using Bluetooth to transfer your therapy results to the DreamMapper app. If your product is eligible for extended warranty, first you need aMyPhilipsaccount. DreamMapper v 2.31.0.3 Koninklijke Philips N.V., 2004-2023 All rights reserved. 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. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation. Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines If you have been informed that you can extend your warranty, first you need a My Philips account. Register your product and start enjoying benefits right away. 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. Create account Create an account Already have an account? 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. 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. With Philips Respironics focusing on the recall, the U.S. CPAP/APAP/BiPAP supply was cut in half overnight. Philips Recalls Sleep Ventilators, CPAP Apnea Devices - AARP We learned of this recall at the same time as our customers and have been in daily communication with Philips Respironics since that time. 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 review the DreamStation 2 Setup and Use video for help on getting started. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. Selected products What information do I need to provide to register a product? Please contact your Philips representative if you are in need of a loaner Trilogy Evo device for a patient. This could affect the prescribed therapy and may void the warranty. The company announced that it will begin repairing devices this month and has already started . Then you can register your product. 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. Philips Respironics provides update for the US on ongoing CPAP, BiPAP Dont have one? Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. All of the relationships we hold dear, our family, friends, coworkers, and customers are affected. Many dealers expect to run out and go through at least intermittent back order periods for the foreseeable future. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Cant Afford a New CPAP Machine? What devices have you already begun to repair/replace? 2. We will continue to take any actions Philips Respironics or the organizations governing them approve relating to this recall as quickly as we are able to execute them. 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. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. Once set, the device will automatically start at the selected Ramp Plus pressure with all future therapy sessions. Philips Respironics continues to monitor recall awareness for affected patients [1]. We recommend you upload your proof of purchase, so you always have it in case you need it. Register - Philips Respironics DreamMapper If you do not have a second device available we suggest you print out the instructions. Further testing and analysis is ongoing. Success. Create a new password following the password guidelines. Philips Respironics will continue with the remediation program. If you already have a DreamMapper account but do not remember your Username, please note that your Username is your email address. Philips DreamStation 2 . In that case, your use of the service provided in this application through collection of personal information may be restricted. In order to unlock DreamMappers full capabilities you will need to provide the Device Serial number that is on your Philips Sleep Therapy Device. Log in (This includes a request for temporary suspension of the 90-day adherence rule for continued coverage of a PAP 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. One of the more complex aspects of the recall has been creating remediation options for all variations of affected devices. We created this helpful guide to finding a low-cost CPAP machine if you cant afford to purchase a new machine. All rights reserved. Click Submit to create your account. Request service | Philips The App uses Apptentive, a feedback and communication service ("Apptentive") provided by Apptentive Inc. Apptentive uses a technology similar to a "cookie" in order to help the App analyze overall traffic patterns and collect your feedback through the App. Philips CPAP and BiLevel PAP Recall - VHA National Center for Patient 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. The Company may provide a part or all of your personal information to a third party to facilitate the work. Proof of purchase is a printed receipt from the shopwhere you purchased your product, or a PDF invoice from an online retailer. All oxygen concentrators, respiratory drug delivery products, airway clearance products. 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. The data shared includes your usage of the device, mask leak measurements, CPAP pressure and your periodic breathing rate. Using a new account on a desktop or laptop. Philips Respironics Sleep and Respiratory Care devices | Philips To improve our service quality and deliver up-to-date information and newsletters (text/email) You can find the list of products that are not affected. Have your DreamStation device serial number available (begins with the letter J and is 13 characters in length). Do not Use, Next You can sign up here. As a result, testing and assessments have been carried out. Improvement of our service quality for better treatment adherence by using this application My product is not working. FDA Green Lights Repair and Replacement Program for Philips DreamStation Recall, How do I know if my device was recalled?, a process he said would likely take a year, helpful guide to finding a low-cost CPAP machine. This approach needs to go through some regulatory hurdles first. You will be using Bluetooth to transfer your therapy results to the DreamMapper app. On Monday, June 14th, Philips Respironics issued a voluntary recall on nearly all of their CPAP, APAP, and BiPAP machines sold from 2009 until today, with some exceptions. 1. As a result, testing and assessments have been carried out. 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. Those who have Medicare are in a similar case-by-case situation. Philips CPAP Recall Foam Removal Guide DreamStation 1 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. We will continue to provide regular updates to you through monthly emails. Cancel. On June 22nd, the American Academy of Sleep Medicine (AASM) and several medical societies and patient advocacy organizations submitted a letter to durable medical equipment (DME) contractors requesting patient support from the Centers for Medicare and Medicaid Services (CMS) since many individuals will be unable to meet CMS adherence requirements before their device can be fixed or replaced. Philips has established a registration process where you can look up your device serial number and begin a claim if your . 6. This recall was announced on June 14, 2021. CPAP.com is a family-owned and operated business dedicated to providing affordable sleep apnea equipment to those who need sleep therapy. If you do not remember your DreamMapper password or need to reset it: Click Forgot Password?. 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. Optional items: Email address and mobile phone number In the article, Dr. Barone discusses the risks of abruptly ending treatment versus using a recalled device. 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. All rights reserved. ** Philips Respironics has provided the data and analyses to the FDA and other competent authorities. 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? 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. Periodically, DreamMapper data is analyzed to determine where improvements can be made to the application and to determine the frequency that functions within the application is used. Purpose of Collection and Use of Sensitive Information 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 . Enter the Captcha characters. Please contact your Philips representative if you are in need of a loaner Trilogy Evo device for a patient. Register your product and enjoy the benefits. 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. Register your device on the Philips recall website or call 1-877-907-7508. Philips issues Dreamstation CPAP recall notification | AASM 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 . 2. To register a new purchase, please have the product on hand and log into your My Philips account. Fill out the registration form (leave Mobile Phone blank). You can sign up here. We have completed all steps with Philips Respironics currently available to help our customers move forward in the process. Duration of Retention and Use of Sensitive Information Product registration To register a new purchase, please have the product on hand and log into your My Philips account. 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. Enter your Username and Password and click Login. 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. 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. As a first step, if your device is affected, please start the registration process here. You can also upload your proof of purchase, so it is stored safely if you need it for service or repair of your product. Our intention is to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. Once the purpose of use is achieved, your personal information will be destroyed immediately, unless otherwise required by laws. Then you can register your product. Philips Respironics will continue with the remediation program. We strongly recommend that customers and patients do not use ozone-related cleaning products. What can I do with a My Philips account? Philips Respironics DreamStation Auto SV - 1800CPAP You can log in or create one here. Purpose of Collection and Use of Personal Information Philips Respironics CPAP Recall Registration Form - YouTube Duration of retention and use of personal information of the receiving parties: Until the purpose of personal information use is achieved This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. Download the app Using your mobile device: Download the DreamMapper app by using the app store buttons above. Koninklijke Philips N.V., 2004 - 2023. There are many reasons people choose to purchase a CPAP machine outright, even if you have health insurance. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. We know that you are eager to find out when youll receive your replacement CPAP, BiPAP or Mechanical Ventilator device. To register a new purchase, please have the product at hand and log into your MyPhilips account. If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. Not all direct-to-consumer brands offer sales and discounts, though. As mentioned, receiving a new device through your insurance plan requires a new prescription from your physician with documentation stating that you are using and benefitting from your sleep apnea treatment. FDA Green Lights Repair and Replacement Program for Philips 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. 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. Please click either Yes or No. You can log in or create one here. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) 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. We are advocating on your behalf to get quicker updates and more information about the situation as it evolves. Further testing and analysis is ongoing. CPAP.com was recently notified by Philips Respironics of a recall for certain CPAP, APAP, and BiPAP devices. Koninklijke Philips N.V., 2004 - 2023. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. 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. 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.