What devices have you already begun to repair/replace? Philips DreamStation 2 . You can also upload your proof of purchase, so you have it, if you need it for service or repairs. 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. 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. 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. Per Philips Respironics, possible health risks include exposure to degraded sound abatement foam and exposure to chemical emissions from the foam material. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. Our experts know CPAP inside and out. The Philips Learning connection hosts educational modules that provide overviews of the DreamStation 2 and DreamStation 2 Advanced. Begin registration process 3163 1432 1800-28-63-020 9am-6pm (Mon-Fri) Acknowledge all consents. Under normal circumstances, most private insurance companies replace your CPAP machine if youve had it for five or more years. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. The affected products are identified in the tables below: All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers, DreamStation ASV DreamStation ST, AVAPS SystemOne ASV4 C-Series ASV C-Series S/T and AVAPS OmniLab Advanced+, SystemOne (Q-Series) DreamStation DreamStation Go Dorma 400 Dorma 500 REMstar SE Auto, Trilogy 100 Trilogy 200 Garbin Plus, Aeris, LifeVent, A-Series BiPAP Hybrid A30 (not marketed in US) A-Series BiPAP V30 Auto, A-Series BiPAP A40 (not marketed in the US) A-Series BiPAP A30 (not marketed in the US). As a result, testing and assessments have been carried out. While Philips recommends patients to discontinue use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment, we understand that many are not satisfied with this answer. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Simplified. Can I trust the new foam? 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. To register a new purchase, please have the product on hand and log into your My Philips account. You are about to visit a Philips global content page. You can log in or create one here. As a result, testing and assessments have been carried out. 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. 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. Apologize for any inconvenience. Please be assured that we are doing all we can to resolve the issue as quickly as possible. As new information and options become available to help our customers we will switch our operations accordingly. Duration of retention and use of personal information of the receiving parties: Until the purpose of personal information use is achieved Are there any recall updates regarding patient safety? 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 . Since hearing the news we have been in daily communication with Philips Respironics to understand what aid we can provide our customers. This recall notification/field safety notice has not yet been classified by regulatory agencies. The recall effects millions of units and replacement isn't coming for a long. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. 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. At the Login Page for DreamMapper, you can register for a new account or login with your existing Username and Password. You can find the list of products that are not affected. You can refuse to provide the Authorization for Collection and Use of Personal Information. This is a potential risk to health. 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.. Please visit mydreammapper.com by clicking the Login button above. With Philips Respironics focusing on the recall, the U.S. CPAP/APAP/BiPAP supply was cut in half overnight. Dont have one? This is a potential risk to health. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. 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. To register your product, youll need to log into your MyPhilips account. Why do I need to upload a proof of purchase? Confirm the new password in the Confirm Password field. Selected products 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*. Philips Respironics Chief Executive Frans van Houten said, Were going to put all our capacity to focus entirely on replacing and repairing these units, a process he said would likely take a year. 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. CPAP.com was recently notified by Philips Respironics of a recall for certain CPAP, APAP, and BiPAP devices. Below is the information you need to know on this recall, how you might be impacted, what next steps should be taken, and what you should expect. To improve treatment adherence by analyzing information of patient's CPAP use and delivering the analysis results to the patient (, Philips Kitchen+ app - tasty airfryer recipes & tips, Register your purchase to unlock the benefits, 1. Have your DreamStation device serial number available (begins with the letter J and is 13 characters in length). Selected products Each day more information becomes available. High heat and high humidity environments as well as unapproved cleaning methods such as ozone, may also contribute to foam degradation. If you already have a DreamMapper account but do not remember your Username, please note that your Username is your email address. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. 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. Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. Access all your product information in one place (orders, subscriptions, etc. Receiving party (contact information):Affiliates other than KoninklijkePhilips N.V.(contact information of responsible division:privacy@philips.com) Once you have successfully logged in, please open the instructions below for specific instructions on how to transfer the data from your current device to DreamMapper. If you already have a DreamMapper account but do not remember your Username, please note that your Username is your email address. 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. 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. 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! We know that you are eager to find out when youll receive your replacement CPAP, BiPAP or Mechanical Ventilator device. Questions about next steps after you have transferred your prescription settings? 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. unapproved cleaning methods such as ozone may contribute to foam degradation. To register your product, youll need to log into your MyPhilips account. Luna 2 CPAP Review: How Does It Compare to the DreamStation? Keep in mind that the CPAP recall is an ongoing situation, so information from your health insurance provider or Medicare may change. Continuing to use an affected device, if a patients health care provider determines that the benefits outweigh the risks identified in the recall notification. You can still file a claim for reimbursement, but keep in mind that reimbursement is fully dependent on your insurance provider. Register your device (s) on Philips' recall website . For further information about the Company's collection and use of personal information, please click the URL below. 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. Click Return to Login after successful password reset. Email: respironics.service10@philips.com. December 2022 update on completed testing for first-generation DreamStation devices . 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. Please visit mydreammapper.com by clicking the Login button above. 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. This App uses Flurry Analytics, an analytics service (Flurry Analytics) provided by Yahoo Inc. This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation. Proof of purchase is a printed receipt from the shopwhere you purchased your product, or a PDF invoice from an online retailer. We encourage you to read it if youre experiencing hardship during this recall. 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. (This includes a request for temporary suspension of the 90-day adherence rule for continued coverage of a PAP device.). Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. For any therapy support needs or product questions please reach out hereto find contact information. 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. In the event of exposure to degraded foam: In the event of exposure to chemical emissions: Yes. After registration, we will notify you with additonal information as it becomes available. Confirm the new password in the Confirm Password field. Mandatory items: Country, name, email address, and serial number of the device used The issue is with the foam in the device that is used to reduce sound and vibration. Select your mask type and specific mask model. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. This could affect the prescribed therapy and may void the warranty. 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. 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. Login with your Username and new Password. If you do not remember your DreamMapper password or need to reset it: Bluetooth pairing and data transfer 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. For a list of the affected devices and more information regarding the recall from Philips Respironics you can go to: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateChapters:00:00 Intro00:44 Find Your Serial Number01:49 Online Form06:05 Demand for CPAP MachinesShop Online: Our Store: https://sleeplay.comCPAP Machines: https://sleeplay.com/collections/cpap-machinesCPAP Masks: https://sleeplay.com/collections/cpap-masksCPAP Cleaning: https://sleeplay.com/collections/cpap-cleaningCPAP Supplies: https://sleeplay.com/collections/cpap-suppliesOxygen Therapy: https://sleeplay.com/collections/oxygen-therapyGo Social:Facebook: https://facebook.com/sleeplaygroundInstagram: https://instagram.com/sleeplaygroundTwitter: https://twitter.com/sleeplayground TikTok: https://tiktok.com/@sleeplaygroundBecome an Affiliate:https://sleeplay.refersion.com/affiliate/registrationFree Consultation:https://calendly.com/sleeplay/respiratory-therapist-consultation 1. Receiving party's purpose of use of personal information: Store the collected information Have the product at hand when registering as you will need to provide the model number. Enter your Username and affected Device Serial number. Register your product and start enjoying benefits right away. You can refuse to provide the Authorization for Collection and Use of Personal Information. The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. In that case, we cannot deliver recent information and newsletters, which is available only through collection of personal information. Further testing and analysis is ongoing. Intuitive. For further information about the Company's collection and use of personal information, please click the URL below. If you have not done so already, please click here to begin the device registration process. We learned of this recall at the same time as our customers and have been in daily communication with Philips Respironics since that time. Below youll find a list of commonly asked questions about the CPAP recall. We have completed all steps with Philips Respironics currently available to help our customers move forward in the process. Register your child's device on the recall website or call (877) 907-7508 for assistance. We understand that any change to your therapy device can feel significant. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. 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%). Dont have one? For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. We strongly recommend that customers and patients do not use ozone-related cleaning products. In some cases, this foam showed signs of degradation (damage) and chemical emissions. Register your product and enjoy the benefits. Patient setup and training. Per Philips Respironics, products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. We Asked A Sleep Doctor About The Recent CPAP RecallHeres What He Said, Ultimate How To Guide: Best Ways To Clean Your CPAP, A Complete Review of the Lumin CPAP Mask Cleaner in 2023, ResMed AirSense 10 CPAP Machine Review Updated 2023 Card-to-Cloud Model, A-Series BiPAP Hybrid A30 (not marketed in US). Once set, the device will automatically start at the selected Ramp Plus pressure with all future therapy sessions. If you are a patient who has been affected by this recall, do not try to remove the foam from your device. 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. DreamMapper is part of the Dream Family from Philips Respironics. . Philips Respironics will continue with the remediation program. Products that are not affected may have different sound abatement foam material, as new materials and technologies have become available over time. You can also upload your proof of purchase, so it is stored safely if you need it for service or repair of your product. CPAP.com is a family-owned and operated business dedicated to providing affordable sleep apnea equipment to those who need sleep therapy. In order to unlock DreamMappers full capabilities you will need to provide the Device Serial number that is on your Philips Sleep Therapy Device. scanning technology for the right mask fit from the start. 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.. 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.