You are about to visit the Philips USA website. 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). 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, 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. 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). You can find the list of products that are not affected. This is a potential risk to health. You can sign up here. Connect your DreamStation Your DreamStation has built-in support for Bluetooth which will connect to your mobile device and transfer your therapy results. 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. 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? To register your product, youll need to log into your MyPhilips account. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. 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. 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. Your patients may receive a DreamStation 2 as a replacement for their affected CPAP device. However, this recall is not a normal circumstance and different insurance companies will have varying courses of action for you to follow. We recently spoke with Dr. Daniel Barone, an Attending Neurologist at New York Presbyterian/Weill Cornell Medical Center, to address some of the questions you may have about the recall and the impact it has on your sleep apnea treatment. DreamMapper is part of the Dream Family from Philips Respironics. We have completed all requests by Philips Respironics and we eagerly await a plan that will allow us to provide actionable solutions to customers. The following products listed are affected by the recall notification / field safety notice: Continuous Ventilator, Minimum Ventilatory Support, Facility Use, Also known as BiPAP Hybrid A30Ventilator (A-Series), Also known as BiPAP A40 Ventilator (A-Series), Also known as BiPAP A30 Ventilator (A-Series). 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. . To register your product, youll need to log into your MyPhilips account. Dont have one? What CPAP machines are on recall? You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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 . To register your product, youll need to. Don't have one? 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. You can change your settings any time if you prefer not to receive these communications. You can log in or create one. 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. Doing this could affect the prescribed therapy and may void the warranty. unapproved cleaning methods such as ozone may contribute to foam degradation. Apologize for any inconvenience. Next
Dont have one? Patient setup and training. 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! The data shared includes your usage of the device, mask leak measurements, CPAP pressure and your periodic breathing rate. If you do not have a second device available we suggest you print out the instructions. Philips Respironics has provided the relevant regulatory agencies with required information related to the launch and implementation of the projected correction and contracted with a third-party vendor to coordinate the recall effort. Register the device on the recall website www.philips.com/src-updates The website provides current information on the status of the recall and how to receive permanent corrective action to. Can I have it repaired? 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). This is a potential risk to health. Please visit mydreammapper.com by clicking the Login button above. 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 . Philips Respironics guidance for healthcare providers and patients remains unchanged. 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.. Dont have one? 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. View/download instructions for Android devices, View/download instructions for Apple devices, Using an existing account on your mobile device. Our experts know CPAP inside and out. Selected products These issues may result in serious injury that can cause permanent impairment or even be life-threatening. 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. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. 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 thank you for your patience as we work to restore your trust. 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. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. What devices have you already begun to repair/replace? Philips Respironics will continue with the remediation program. All rights reserved. Email: respironics.service10@philips.com. Note: If you are using a mask from another manufacturer, please select Mask Not Listed. Further testing and analysis is ongoing. 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. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. 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. 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. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. In the article, Dr. Barone discusses the risks of abruptly ending treatment versus using a recalled device. to help you and your patients succeedtogether. Select your mask type and specific mask model. Please click either Yes or No. Mandatory items: Time of device use as per the patient's use, prescribed pressure, degree of mask leak, and periodic breathing rate
Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. 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. 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. 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. *Trilogy Evo devices provided as loaners do not contain the silicone foam or the affected PE-PUR foam. Enter your Username and Password and click Login. Enter your Username and affected Device Serial number. At the Login Page for DreamMapper, you can register for a new account or login with your existing Username and Password. In summary, the CPAP/APAP/BiPAP machine supply was already tight and shrinking before the recall was announced. You can refuse to provide the Authorization for Collection and Use of Sensitive Information. The issue is with the foam in the device that is used to reduce sound and vibration. 5. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. All rights reserved. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. To register a new purchase, please have the product at hand and log into your MyPhilips account. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Intuitive. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. This is a potential risk to health. 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. 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. We know how important it is to feel confident that your therapy device is safe to use. 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. Select country / language; Breathe easier, sleep more naturally . Products not affected by this recall notification (U.S. only) / field safety notice (International Markets) include: The best way to know if your device is included in the recall is to register your machine for the recall. Your IP address is anonymized prior to use and storage within Apptentive's products and services. What is the advice for patients and customers? Buying a CPAP machine outright offers several advantages and can be the most cost-effective option. 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. 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 issued a voluntary product recall for its breathing devices and ventilators due to sound abatement foam that has a potential to break down. Please visit mydreammapper.com by clicking the Login button above. You can refuse to provide the Authorization for Collection and Use of Personal Information. 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 Many dealers expect to run out and go through at least intermittent back order periods for the foreseeable future. Register your product and enjoy the benefits. Duration of Retention and Use of Personal Information
This recall notification/field safety notice has not yet been classified by regulatory agencies. We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. Koninklijke Philips N.V., 2004 - 2023. 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. is designed . If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. 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. On June 14, 2021, Royal Philips' subsidiary, Philips Respironics, initiated a voluntary recall notification * for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. Providing DreamMapper with the mask that you use for your therapy will allow us to assist you in obtaining good mask fit. We are advocating on your behalf to get quicker updates and more information about the situation as it evolves. By clicking on the link, you will be leaving the official Philips Electronics Ltd. ("Philips") website. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) Note: Please use the same email address you used when registering your device for the voluntary recall. A patient no longer needs to tap a Ramp button every night to start at the desired pressure. 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. If you already have a DreamMapper account but do not remember your Username, please note that your Username is your email address. In that case, your use of the service provided in this application through collection of personal information may be restricted. The company announced that it will begin repairing devices this month and has already started . Please be assured that we are doing all we can to resolve the issue as quickly as possible. Continuing to use an affected device, if a patients health care provider determines that the benefits outweigh the risks identified in the recall notification. 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. 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. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). 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. December 2022 update on completed testing for first-generation DreamStation devices . Product Support: 541-598-3800. Last year the FDA issued a safety communication about PAP cleaners. 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 App uses Flurry Analytics, an analytics service (Flurry Analytics) provided by Yahoo Inc. To improve treatment adherence by analyzing information of patient's CPAP use and delivering the analysis results to the patient
Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. Can I trust the new foam? 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. 1. 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. Receiving party's purpose of use of personal information: Store the collected information
Further testing and analysis is ongoing. You can. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. Koninklijke Philips N.V., 2004 - 2023. Note: Please use the same email address you used when registering your device for the voluntary recall. Improvement of our service quality for better treatment adherence by using this application
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. Create a new password following the password guidelines. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Method of provision:Electronically transfer immediately upon authorization for collection and use of personal information
My product is not working. If the product does not perform after following the FAQs & troubleshooting steps. Koninklijke Philips N.V., 2004 - 2023. Have the product at hand when registering as you will need to provide the model number. 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. Please read carefully and fully understand all terms of "Service Agreement" and "Privacy Policy", including but not limited to: to provide you with services of your usage of the device, we need to collect personal information like information about your device,operation log, etc.. You can view, change, delete personal information and manage your authorization at "Settings". 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. 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.. Further testing and analysis is ongoing. Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. 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. ** Philips Respironics has provided the data and analyses to the FDA and other competent authorities. 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. We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. Fill out the registration form (leave Mobile Phone blank). 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Youcan also upload your proof of purchase, so it is stored safely if you need it for service or repair of your product. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . 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. 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.. You can also upload your proof of purchase, so you have it, if you need it for service or repairs. One of the more complex aspects of the recall has been creating remediation options for all variations of affected devices. Create account Create an account Already have an account? This is not our choice or our preference. We recommend you upload your proof of purchase, so you always have it in case you need it. 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. 2. The website will give you instructions on how to locate the serial number of your device. 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. Countries where the receiving parties are located:Japan, Europe, etc. Since CPAP.com does not bill insurance or accept Medicare, we are able to offer you the lowest priced machines. Why do I need to upload a proof of purchase? scanning technology for the right mask fit from the start. Using a new account on a desktop or laptop. If you are a patient who has been affected by this recall, do not try to remove the foam from your device. Duration of Retention and Use of Personal Information
Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Register your purchase to unlock the benefits, 1. First Night Guide. Simplified. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. DreamMapper has the ability to share your therapy data with your Home Care Providers electronic health records system. Accept terms and conditions. There are many reasons people choose to purchase a CPAP machine outright, even if you have health insurance. Items of Personal Information to be Collected
When you refuse to provide the authorization, you may have limited service provided through collection of personal information. Auto CPAP Advanced. Create a new password following the password guidelines. What is the safety issue with the device?
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, possible health risks include exposure to degraded sound abatement foam and exposure to chemical emissions from the foam material. Under normal circumstances, most private insurance companies replace your CPAP machine if youve had it for five or more years. If you do not have a second device available we suggest you print out the instructions. Additionally, Philips Respironics suggests patients review the age of their devices, as they are typically recommended to be replaced after five years of use. Not all direct-to-consumer brands offer sales and discounts, though. Click Next. Below youll find a list of commonly asked questions about the CPAP recall. Philips Respironics will continue with the remediation program. If you do not have a second device available we suggest you print out the instructions. Why do I need to upload a proof of purchase? Please review the attached. Receiving party (contact information):Affiliates other than KoninklijkePhilips N.V.(contact information of responsible division:privacy@philips.com)
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. 1. The Dream Family offers innovative, comprehensive sleep therapy technology like: . 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. Each day more information becomes available. We have trained service professionals on hand who can make sure that the affected foam is completely removed, safely, and that the new silicone foam is inserted correctly. As a result, testing and assessments have been carried out. 1875 Buckhorn Gate, 5th Floor, Mississauga, Ontario L4W 5P1. In that case, your use of the service provided in this application through collection of sensitive information may be restricted. You can sign up here. Heres How to Get Low-Cost or Free CPAP Supplies! Also known as DreamStation BiPAP autoSV, Also known as DreamStation BiPAP AVAPS, DreamStation BiPAP S/T, Also known as System One BiPAP autoSV, System One BiPAP autoSV Advanced, Also known as System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series), Also known as BiPAP Hybrid A30Ventilator (A-Series) (not marketed in US), Also known as BiPAP V30 Auto Ventilator (A-Series), Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US), Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US). CPAP.com does not and has never sold ozone-related cleaning products. 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. 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. Flurry will not associate your IP address with any other data held by Flurry. With regard to mechanical ventilators, Philips is deploying a permanent corrective action to address the issues described in the recall notification. Once the purpose of use is achieved, your personal information will be destroyed immediately, unless otherwise required by laws. If you do not remember your DreamMapper password or need to reset it: Click Forgot Password?. 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. (, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. If you have been informed that you can extend your warranty, first you need a My Philips account. You may have a high deductible or perhaps you have preferences for a specific vendor that isnt covered under your current policy. 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. The DreamStation 2 CPAP Advanced is designed to provide a simplified user experience, including a premium color touchscreen with fewer panes to navigate.
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.