What information do I need to provide to register a product? 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. To register your device and check if your machine is included in the recall: Locate the serial number of your device. Please click either Yes or No. If you do not have a second device available we suggest you print out the instructions. 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. Your patients may receive a DreamStation 2 as a replacement for their affected CPAP device. Proof of purchase may be required to take advantage of a promotion or request a repair within warranty. Acknowledge all consents. Philips Respironics Sleep and Respiratory Care devices | Philips 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. 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? Please review the DreamStation 2 Setup and Use video for help on getting started. You should have received a letter from Philips about this issue that contains log-in credentials for the registration website. No matter what type of health insurance coverage you have, you should call your health insurance group soon to see which steps you need to take once youve registered your device and spoken with your doctor. This App uses Flurry Analytics, an analytics service (Flurry Analytics) provided by Yahoo Inc. Dont have one? 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.. For further information about the Company's collection and use of personal information, please click the URL below. Philips issues Dreamstation CPAP recall notification | AASM We thank you for your patience as we work to restore your trust. You can change your settings any time if you prefer not to receive these communications. Register your product and enjoy the benefits. You are about to visit a Philips global content page. Login with your Username and new Password. To register your product, youll need to log into your MyPhilips account. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. Register - Philips Respironics DreamMapper Philips Respironics provides update on filed MDRs in connection with Even Auto ON is enabled so that all you have to do is put your mask on and start breathing. How are you removing the old foam safely? 1. Items of personal information provided: Country, name, email address, device serial number, and telephone number Philips Respironics To register your product, youll need to log in to your My Philips account. The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. You can refuse to provide the Authorization for Collection and Use of Personal Information. Philips DreamStation 2 . 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. Click Return to Login after successful password reset. Don't have one? ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. All rights reserved. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. You can also upload your proof of purchase should you need it for any future service or repairs needs. Please know that your health and safety is our main priority, as we work through this process. To register your product, youll need to log into your MyPhilips account. All rights reserved. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. 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. The DreamStation 2 CPAP Advanced is designed to provide a simplified user experience, including a premium color touchscreen with fewer panes to navigate. We agree. This is not our choice or our preference. Philips provides update on completed set of test results for first 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. 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. 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 Plus, most insurance companies require you to rent your equipment for a certain period of time and many require compliance monitoring to protect their investment. 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. Koninklijke Philips N.V., 2004 - 2023. This is a potential risk to health. Improvement of our service quality for better treatment adherence by using this application As a result, testing and assessments have been carried out. 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. 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. Click Save. We have notified all customers affected by the recall through email and each customer will shortly receive a physical mailed notice. Selected products To register your product, you'll need to log into your MyPhilips account. You will be using Bluetooth to transfer your therapy results to the DreamMapper app. Flurry will not associate your IP address with any other data held by Flurry. We will continue to provide regular updates to you through monthly emails. The data shared includes your usage of the device, mask leak measurements, CPAP pressure and your periodic breathing rate. Koninklijke Philips N.V., 2004 - 2023. Purpose of Collection and Use of Personal Information In that case, we cannot deliver recent information and newsletters, which is available only through collection of personal information. 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 regard to mechanical ventilators, Philips is deploying a permanent corrective action to address the issues described in the recall notification. Click Next. ** Philips Respironics has provided the data and analyses to the FDA and other competent authorities. 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. You can find the list of products that are not affected. If your product is eligible for extended warranty, first you need aMyPhilipsaccount. Dont have one? You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Please be assured that we are treating this matter extremely seriously, and are working to address this issue as efficiently and thoroughly as possible. FAQ 1. 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. 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. Confirm the new password in the Confirm Password field. As we learn more, we will update our customers via email and the CPAP community at large using this blog. The Philips Learning connection hosts educational modules that provide overviews of the DreamStation 2 and DreamStation 2 Advanced. 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. 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. To improve our service quality and deliver up-to-date information and newsletters (text/email) Have the product at hand when registering as you will need to provide the model number. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Can I have it repaired? Confirm the new password in the Confirm Password field. Enter your Username and affected Device Serial number. 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%). Success. Register your child's device on the recall website or call (877) 907-7508 for assistance. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. Why do I need to upload a proof of purchase? What is the safety issue with the device? Sleep respiratory recall | Philips The FDA is still considering the data and analyses that Philips Respironics has provided and may reach different conclusions. Koninklijke Philips N.V., 2004 - 2023. 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. Philips Respironics CPAP Recall Registration Form - YouTube 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. You can find the list of products that are not affected here. Please open the DreamMapper app on your mobile device and enter your Username and Password and click Login. Notice for Sleep Apnea Patients Using Philips Respironics CPAP/BiPAP 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. 1. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. 3. Under normal circumstances, most private insurance companies replace your CPAP machine if youve had it for five or more years. To register a new purchase, please have the product on hand and log into your My Philips account. You can also upload your proof of purchase, so it is stored safely if you need it for service or repair of your product. 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. Download the app Using your mobile device: Download the DreamMapper app by using the app store buttons above. Since the news broke, customers have let us know they are frustrated and concerned. 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 . We strongly recommend that customers and patients do not use ozone-related cleaning products. What devices have you already begun to repair/replace? Create a new password following the password guidelines. Apologize for any inconvenience. This recall was announced on June 14, 2021. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. If you have not done so already, please click here to begin the device registration process. In the event of exposure to degraded foam: In the event of exposure to chemical emissions: Yes. *Trilogy Evo devices provided as loaners do not contain the silicone foam or the affected PE-PUR foam. Since CPAP.com does not bill insurance or accept Medicare, we are able to offer you the lowest priced machines. 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. If you do not remember your DreamMapper password or need to reset it: Click Forgot Password?. This is a realistic look at what you can expect when removing the Foam from your recalled Philips DreamStation 1. 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. 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. Next How it works. Those risks include but are not limited to headaches, nausea, irritation of the eyes, nose or skin or potential cancer . Select your mask type and specific mask model. 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 This could affect the prescribed therapy and may void the warranty. Do not Use, Next These issues may result in serious injury that can cause permanent impairment or even be life-threatening. 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. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. Luna 2 CPAP Review: How Does It Compare to the DreamStation? We have completed all steps with Philips Respironics currently available to help our customers move forward in the process. We encourage you to read it if youre experiencing hardship during this recall. 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. Philips Respironics guidance for healthcare providers and patients remains unchanged. You can refuse to provide the Authorization for Collection and Use of Personal Information. Shop now Item # DSX520H11C Not currently in stock Dreamstation 2 Auto CPAP with Humidifier Overview Philips Respironics Mask Selector uses no-touch. Agree Are there any recall updates regarding patient safety? Per Philips Respironics, the issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. Have the product at hand when registering as you will need to provide the model number. We recommend you upload your proof of purchase, so you always have it in case you need it. How can I register my product for an extended warranty? 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. 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. Optional items: Email address and mobile phone number We strongly recommend that customers and patients do not use ozone-related cleaning 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. Product registration | Philips 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. 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.. As a result, testing and assessments have been carried out. FDA Green Lights Repair and Replacement Program for Philips 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. The issue is with the foam in the device that is used to reduce sound and vibration. Register your device (s) on Philips Respironics' recall website to stay informed of updates from Philips Respironics regarding any new instructions or other corrective fixes, which the. is designed . This spreadsheet provides Medicare DME fee schedule information, by HCPCS code . This is a potential risk to health. 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. Koninklijke Philips N.V., 2004 - 2023. Approve a rental device of the same caliber and quality as your original equipment, Determine that the recall voids the standard replacement requirement and immediately replace the device, Deny covering the cost of a new machine at this time.