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 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? You can find the list of products that are not affected. 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. Using alternative treatments for sleep apnea. If your product is eligible for extended warranty, first you need aMyPhilipsaccount. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. The recall effects millions of units and replacement isn't coming for a long. When you refuse to provide the authorization, you may have limited service provided through collection of personal information. 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 . All rights reserved. How it works. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Call1.800.356.5221M-F 8AM-8PM | Sa 8AM-5PM (CST). 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. 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 are partnering with clinicians and business customers throughout this process to ensure were doing all we can to help you and your healthcare needs. Method of provision:Electronically transfer immediately upon authorization for collection and use of personal information Even Auto ON is enabled so that all you have to do is put your mask on and start breathing. Philips Respironics received authorization from the U.S. Food and Drug Administration (FDA) to restore affected first-generation DreamStation devices by replacing the PE-PUR sound abatement foam with a new material. Email: respironics.service10@philips.com. 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. 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. We recommend you upload your proof of purchase, so you always have it in case you need it. 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. It also will guide you through the registration process. Please open the DreamMapper app on your mobile device and enter your Username and Password and click Login. You are about to visit a Philips global content page. Apologize for any inconvenience. Please note that it is important that you only use approved cleaning methods for our devices and masks, as unapproved cleaning methods such as ozone may contribute to foam degradation. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. If you do not have a second device available we suggest you print out the instructions. The DreamStation 2 CPAP Advanced is designed to provide a simplified user experience, including a premium color touchscreen with fewer panes to navigate. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Give us a call today and one of our 5 star customer service representatives will help you. 2. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. To register your product, youll need to log into your MyPhilips account. As part of the remediation process, customers and patients will be provided with more information on the next steps to implement the permanent solution as it becomes available. The advocacy demonstrated by the AASM has not been confirmed as a solution from CMS, however, so the best course of action is to call your Medicare or Medicaid provider directly regarding new sleep studies, reimbursement for repair costs, or the issuance of a new device. Register your product and enjoy the benefits. 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). We will continue to provide regular updates to you through monthly emails. One of the more complex aspects of the recall has been creating remediation options for all variations of affected devices. DreamStation Go: Whether you're traveling for business or venturing out on the vacation of a lifetime, DreamStation Go provides an easy, reliable and portable PAP experience for users who . Buying a CPAP machine outright offers several advantages and can be the most cost-effective option. 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 know that your health and safety is our main priority, as we work through this process. Click Submit to create your account. To improve treatment adherence by analyzing information of patient's CPAP use and delivering the analysis results to the patient DreamMapper is part of the Dream Family from Philips Respironics. 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. Please contact your Philips representative if you are in need of a loaner Trilogy Evo device for a patient. 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. Unlike the DreamStation CPAP device, the DreamStation 2 CPAP Advanced device features the Ramp Plus feature where a user can select a comfortable start pressure. Download the app Using your mobile device: Download the DreamMapper app by using the app store buttons above. To register your product, youll need to log into your MyPhilips account. Acknowledge all consents. 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. Mandatory items: Country, name, email address, and serial number of the device used 2. Your IP address is anonymized prior to use and storage within Apptentive's products and services. 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. You can find the list of products that are not affected here. 1. Using a new account on a desktop or laptop. Receiving party's purpose of use of personal information: Store the collected information Enter your Username and affected Device Serial number. Duration of Retention and Use of Personal Information You are about to visit a Philips global content page. You can also upload your proof of purchase, so you have it, if you need it for service or repairs. 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. Register your product and start enjoying benefits right away. This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation. Login with your Username and new Password. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. My product is not working. The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. In some cases, this foam showed signs of degradation (damage) and chemical emissions. Additionally, Philips Respironics suggests patients review the age of their devices, as they are typically recommended to be replaced after five years of use. CPAP.com was recently notified by Philips Respironics of a recall for certain CPAP, APAP, and BiPAP devices. Enter your Username and affected Device Serial number. You will be using Bluetooth to transfer your therapy results to the DreamMapper app. Dont have one? 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). Since hearing the news we have been in daily communication with Philips Respironics to understand what aid we can provide our customers. 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. Can I have it repaired? 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. 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. Please note that it is important that you only use approved cleaning methods for our devices and masks, as, We know how important it is to feel confident that your therapy device is safe to use. Confirm the new password in the Confirm Password field. Once the purpose of use is achieved, your personal information will be destroyed immediately, unless otherwise required by laws. 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 issued a voluntary product recall for its breathing devices and ventilators due to sound abatement foam that has a potential to break down. 1875 Buckhorn Gate, 5th Floor, Mississauga, Ontario L4W 5P1. We thank you for your patience as we work to restore your trust. Click Save. If your product is eligible for extended warranty, first you need aMyPhilipsaccount. Your patients may receive a DreamStation 2 as a replacement for their affected CPAP device. To register a new purchase, please have the product on hand and log into your My Philips account. 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. You may have a high deductible or perhaps you have preferences for a specific vendor that isnt covered under your current policy. Unlike the DreamStation CPAP device, the DreamStation 2 CPAP Advanced device features the Ramp Plus feature where a user can select a comfortable start pressure. 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. 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. In that case, your use of the service provided in this application through collection of sensitive information may be restricted. Cant Afford a New CPAP Machine? The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. Further testing and analysis is ongoing. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. 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. Many dealers expect to run out and go through at least intermittent back order periods for the foreseeable future. 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. This spreadsheet provides Medicare DME fee schedule information, by HCPCS code . In the article, Dr. Barone discusses the risks of abruptly ending treatment versus using a recalled device. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. 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. Keep in mind that the CPAP recall is an ongoing situation, so information from your health insurance provider or Medicare may change. As we learn more, we will update our customers via email and the CPAP community at large using this blog. 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. Register your product and enjoy the benefits. Youcan also upload your proof of purchase, so it is stored safely if you need it for service or repair of your product. Click Next. With regard to mechanical ventilators, Philips is deploying a permanent corrective action to address the issues described in the recall notification. Your individual coverage with Medicare or Medicaid will determine how to proceed with your device. If you already have a DreamMapper account but do not remember your Username, please note that your Username is your email address. This could affect the prescribed therapy and may void the warranty. Register your product and enjoy the benefits. Questions about registering, signing in or need any otherDreamMapper support? Not all direct-to-consumer brands offer sales and discounts, though. Items of Sensitive Information to be Collected Enter your Username and Password and click Login. 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. Since CPAP.com does not bill insurance or accept Medicare, we are able to offer you the lowest priced machines. Plus, it usually isnt as complicated as purchasing a new device through insurance. Countries where the receiving parties are located:Japan, Europe, etc. By clicking on the link, you will be leaving the official Philips Electronics Ltd. ("Philips") website. 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. How can I register my product for an extended warranty? Improvement of our service quality for better treatment adherence by using this application What devices have you already begun to repair/replace? The recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). 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. What is the advice for patients and customers? If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. We understand that any change to your therapy device can feel significant. We encourage you to read it if youre experiencing hardship during this recall. We learned of this recall at the same time as our customers and have been in daily communication with Philips Respironics since that time. 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. You can create one here. Register - Philips Respironics DreamMapper Register Country* First Name Last Name Email Address* Confirm Email Address* Mobile Phone Primary Device Serial Number I understand and accept the Terms and Conditions. The issue is with the foam in the device that is used to reduce sound and vibration. Please review the DreamStation 2 Setup and Use video for help on getting started. Once the purpose of use is achieved, your personal information will be destroyed immediately, unless otherwise required by laws. Flurry will not associate your IP address with any other data held by Flurry. 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*. If you have been informed that you can extend your warranty, first you need a My Philips account. This process should take about 10 minutes to complete, but may vary based on internet speed or device used. You can refuse to provide the Authorization for Collection and Use of Personal Information. 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. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. In order to unlock DreamMappers full capabilities you will need to provide the Device Serial number that is on your Philips Sleep Therapy Device. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. Sharing your sleep therapy data provides them insight on how you are complying with your prescribed sleep therapy regimen. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Please visit mydreammapper.com by clicking the Login button above. CPAP.com does not and has never sold ozone-related cleaning products. 2. 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. We are advocating on your behalf to get quicker updates and more information about the situation as it evolves. CPAP.com is a family-owned and operated business dedicated to providing affordable sleep apnea equipment to those who need sleep therapy. This recall notification/field safety notice has not yet been classified by regulatory agencies. You should have received a letter from Philips about this issue that contains log-in credentials for the registration website. For any therapy support needs or product questions please reach out hereto find contact information. 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. 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. What can I do with a My Philips account? 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 allow us to use this information for marketing purposes, we may send you marketing messages based on your device model. If you do not have a second device available we suggest you print out the instructions. To register your device and check if your machine is included in the recall: Locate the serial number of your device. 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. Confirm the new password in the Confirm Password field. Philips Respironics guidance for healthcare providers and patients remains unchanged. 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 a new password following the password guidelines. *Trilogy Evo devices provided as loaners do not contain the silicone foam or the affected PE-PUR foam. Apologize for any inconvenience. Patient setup and training. Access all your product information in one place (orders, subscriptions, etc. After youve registered your machine with Philips and have scheduled an appointment with your sleep care physician to discuss a new treatment plan, you may be wondering if you should keep using your recalled machine and what options exist if you decide its time to purchase a new machine altogether. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Philips Sleep and respiratory care. As a result, testing and assessments have been carried out. You are about to visit the Philips USA website. Further testing and analysis is ongoing. 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. How it works 1. 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. Click Save. Always follow manufacturer-recommended cleaning instructions. 5. 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 . 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. 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 .