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. 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. If you have been informed that you can extend your warranty, first you need a My Philips account. You can log in or create one. We strongly recommend that customers and patients do not use ozone-related cleaning products. We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. We encourage you to read it if youre experiencing hardship during this recall. As a result, testing and assessments have been carried out. Click Next. 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. DreamMapper data is also analyzed to determine the number of patients that are using DreamStation related products as well as other Philips products. Purpose of Collection and Use of Personal Information Philips Respironics provides update for the US on ongoing CPAP, BiPAP You should have received a letter from Philips about this issue that contains log-in credentials for the registration website. What information do I need to provide to register a product? . You are about to visit the Philips USA website. Items of personal information provided: Country, name, email address, device serial number, and telephone number One of the more complex aspects of the recall has been creating remediation options for all variations of affected devices. IMPORTANT: If a humidifier was included with your sleep therapy device, be sure to remove the water chamber before you proceed. 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. The affected products are identified in the tables below: A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP A40 (not marketed in the US), A-Series BiPAP A30 (not marketed in the US), Products that are not affected may have different sound abatement foam material, as new materials and technologies have become available over time. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. By transmitting the information generated by the cookie about the use of the App to Flurry, your setting ensures that IP address is anonymized before geo-localization and will be replaced by a generic IP address before storage. scanning technology for the right mask fit from the start. 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. Enter your Username and affected Device Serial number. 6. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Philips Respironics will continue with the remediation program. To improve our service quality and deliver up-to-date information and newsletters (text/email) 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. 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.. 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. Philips Respironics Recalls Certain Continuous and Non-Continuous 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. Begin SD data card transfer 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. You can also upload your proof of purchase should you need it for any future service or repairs needs. Note: Please use the same email address you used when registering your device for the voluntary recall. Please contact your Philips representative if you are in need of a loaner Trilogy Evo device for a patient. 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. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. Confirm the new password in the Confirm Password field. 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. 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). If your prescription has expired, its worth considering a home sleep testwhich lets you complete a sleep study from the comfort of your own bedto renew your prescription. In that case, your use of the service provided in this application through collection of personal information may be restricted. Philips Respironics Mask Selector uses no-touch. Patient setup and training. 2. 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. You can sign up here. As we learn more, we will update our customers via email and the CPAP community at large using this blog. This process should take about 10 minutes to complete, but may vary based on internet speed or device used. 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. There are currently no items in your shopping cart. You can refuse to provide the Authorization for Collection and Use of Personal Information. I O 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. In the article, Dr. Barone discusses the risks of abruptly ending treatment versus using a recalled device. In the interim, in specific markets, a Trilogy Evo device can be made available for patients currently using affected Trilogy 100 and 200 devices. Please review the attached. Receiving party (contact information):Affiliates other than KoninklijkePhilips N.V.(contact information of responsible division:privacy@philips.com) Connect your DreamStation Your DreamStation has built-in support for Bluetooth which will connect to your mobile device and transfer your therapy results. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. This means you can set the Ramp Plus presusre once and there is no need to restart it each night. This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation. Further testing and analysis is ongoing. To register a product you need: MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). If you have not done so already, please click here to begin the device registration process. What information do I need to provide to register a product? Not all details of this recall are known at this time. September 02, 2021. Sleep respiratory recall | Philips You can prevent Flurrys and Philips' collection and use of data (cookies and IP address) if you opt-out after you close this screen. Access all your product information in one place (orders, subscriptions, etc. As a first step, if your device is affected, please start the. 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. 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 Sleep and Respiratory Care Devices - Australia and New Zealand Register your device On April 26, 2021, Philips globally provided an important update to the market regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio. *Trilogy Evo devices provided as loaners do not contain the silicone foam or the affected PE-PUR foam. Philips Respironics DreamStation CPAP Machine: Two-years limited warranty DeVilbiss IntelliPAP Standard CPAP Machine: Five-year warranty Somnetics Transcend EZEX miniCPAP Machine: Three-year warranty Manufacturer warranties actually begin on the day you buy the CPAP machine from the manufacturer. Register your product and enjoy the benefits. If you do not remember your DreamMapper password or need to reset it: Click Forgot your password?. Philips Respironics CPAP Recall Registration Form - YouTube Philips CPAP and BiLevel PAP Recall - VHA National Center for Patient If you do not have a second device available we suggest you print out the instructions. 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Note: Please use the same email address you used when registering your device for the voluntary recall. If you do not have a second device available we suggest you print out the instructions. Duration of Retention and Use of Personal Information If the product does not perform after following the FAQs & troubleshooting steps. Information for patients and caregivers | Philips By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. When you provide the Authorization for Collection and Use of Personal Information below, you can use services for improved enhance treatment adherence through this application. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. unapproved cleaning methods such as ozone may contribute to foam degradation. The DreamStation 2 CPAP Advanced is designed to provide a simplified user experience, including a premium color touchscreen with fewer panes to navigate. PDF URGENT: Medical Device Recall - Philips 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. 2. Enter your Username and Password and click Login. All oxygen concentrators, respiratory drug delivery products, airway clearance products. Have the product at hand when registering as you will need to provide the model number. Philips Respironics continues to monitor recall awareness for affected patients [1]. 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. You can log in or create one here. We have completed all requests by Philips Respironics and we eagerly await a plan that will allow us to provide actionable solutions to customers. Purpose of Collection and Use of Personal Information You can still register your device on DreamMapper to view your therapy data. What is the advice for patients and customers? 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. Philips Respironics offers innovative products for sleep and home respiratory care as well as medical education and value-added programs to help you navigate a rapidly changing industry landscape, and in the interest of maximizing both clinical and business success. Notice for Sleep Apnea Patients Using Philips Respironics CPAP/BiPAP If your product is eligible for extended warranty, first you need aMyPhilipsaccount. Optional item: Mobile phone number Don't have one? 5. The website will give you instructions on how to locate the serial number of your device. For further information about the Company's collection and use of personal information, please click the URL below. Philips CPAP and BiLevel PAP Recall - VHA National Center for Patient 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. DreamMapper v 2.31.0.3 Koninklijke Philips N.V., 2004-2023 All rights reserved. Click Save. Questions about next steps after you have transferred your prescription settings? In that case, your use of the service provided in this application through collection of sensitive information may be restricted. Auto CPAP Advanced. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Information for Philips Respironics DreamStation users, How to transfer prescription settings from youraffected device so Philips Respironics can begin to prepare your replacement device, Using a new account on your mobile device. What CPAP machines are on recall? In the event of exposure to degraded foam: In the event of exposure to chemical emissions: Yes. First Night Guide. 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. If you do not have this letter, please call the number below. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. Your IP address is anonymized prior to use and storage within Apptentive's products and services. 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. To register your product, youll need to. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. You are about to visit the Philips USA website. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Philips CPAP Recall Lawsuit Update - 2022 Settlement Information 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. 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. Acknowledge all consents. Respironics Recall - UR Medicine Sleep Center - University of Rochester 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. 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. CPAP.com is a family-owned and operated business dedicated to providing affordable sleep apnea equipment to those who need sleep therapy. Purpose of Collection and Use of Sensitive Information Product registration | Philips Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. Login with your Username and new Password. Why do I need to upload a proof of purchase? 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. How can I register my product for an extended warranty? Success. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. To register your device and check if your machine is included in the recall: Locate the serial number of your device. Philips Sleep and respiratory care. This process should take about 10 minutes to complete, but may vary based on internet speed or device used. 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. View/download instructions for Android devices, View/download instructions for Apple devices, Using an existing account on your mobile device. December 2022 update on completed testing for first-generation DreamStation devices . Per Philips Respironics, possible health risks include exposure to degraded sound abatement foam and exposure to chemical emissions from the foam material. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. A patient no longer needs to tap a Ramp button every night to start at the desired pressure. It also will guide you through the registration process. How to Register Your Philips SRC Medical Device - YouTube Give us a call today and one of our 5 star customer service representatives will help you. You can refuse to provide the Authorization for Collection and Use of Personal Information. 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). This approach needs to go through some regulatory hurdles first. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Last year the FDA issued a safety communication about PAP cleaners. 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. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. To register your product, youll need to log into your MyPhilips account. For further information about the Company's collection and use of personal information, please click the URL below. You can refuse to provide the Authorization for Collection and Use of Personal Information. 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.