After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. We recommend you upload your proof of purchase, so you always have it in case you need it. For more information about how DreamMapper processes your data click here. 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. You can refuse to provide the Authorization for Collection and Use of Personal Information. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. 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. View/download instructions for desktop and laptop, Using an existing account on a desktop or laptop. Click Next. 5. 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. Selected products Please open the DreamMapper app on your mobile device and enter your Username and Password and click Login. You can log in or create one. on the latest safety communications from the FDA. 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. Patient setup and training. Products that are not affected may have different sound abatement foam material, as new materials and technologies have become available over time. In many cases when a product doesnt perform as you would expect, the problem can be resolved at home through basic troubleshooting. Acknowledge all consents. 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. This process should take about 10 minutes to complete, but may vary based on internet speed or device used. Apologize for any inconvenience. As this is an official recall, Philips Respironics must adhere to the regulatory requirements of a recall and specify the steps dealers, such as CPAP.com, must follow to adhere to the recall. Enter your Username and affected Device Serial number. You can. We will continue to provide regular updates to you through monthly emails. Further testing and analysis is ongoing. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to register your CPAP machine / BIPAP machine/mechanical ventilator devices for the Philips Respironics Recall. High heat and high humidity environments as well as unapproved cleaning methods such as ozone, may also contribute to foam degradation. 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. The Philips Learning connection hosts educational modules that provide overviews of the DreamStation 2 and DreamStation 2 Advanced. 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 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. DreamMapper has the ability to share your therapy data with your Home Care Providers electronic health records system. Koninklijke Philips N.V., 2004 - 2023. What is the advice for patients and customers? To register a product you need: MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). FAQ 1. 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. With Philips Respironics focusing on the recall, the U.S. CPAP/APAP/BiPAP supply was cut in half overnight. 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. You can also upload your proof of purchase, so it is stored safely if you need it for service or repair of your product. Bluetooth pairing and data transfer Once you have created your account, please select your mobile device operating system below for specific instructions on how to transfer the data from your current device to DreamMapper. 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). Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Accept terms and conditions. In that case, your use of the service provided in this application through collection of personal information may be restricted. Items of Personal Information to be Collected Please review the DreamStation 2 Setup and Use video for help on getting started. Fill out the registration form (leave Mobile Phone blank). Philips Respironics is initiating its repair and replacement program in other countries and expects the program to be underway in most markets by the end of September 2021. For those who cannot currently afford new equipment but who have been encouraged to continue their sleep apnea treatment, weve included a few solutions at the end of this article that we hope can be beneficial to you. 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 includes Dreamstation, Dreamstation Go, Dreamstation ASV/ST/AVAPS, System One, and Remstar SE Auto . As a first step, if your device is affected, please start the. We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. You can find the list of products that are not affected. As we learn more, we will update our customers via email and the CPAP community at large using this blog. Many dealers expect to run out and go through at least intermittent back order periods for the foreseeable future. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. How are you removing the old foam safely? 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 recommend you upload your proof of purchase, so you always have it in case you need it. 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. Dont have one? To register your product, youll need to log into your MyPhilips account. Koninklijke Philips N.V., 2004 - 2023. The website will give you instructions on how to locate the serial number of your device. Register your product and start enjoying benefits right away. Using alternative treatments for sleep apnea. You can sign up here. 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. scanning technology for the right mask fit from the start. As a result, testing and assessments have been carried out. 2. We will continue to provide regular updates to you through monthly emails. 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. 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 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. To register your device and check if your machine is included in the recall: Philips Respironics plans to replace the current sound abatement foam with a new material that is not affected by this issue. We thank you for your patience as we work to restore your trust. Our intention is to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. unapproved cleaning methods such as ozone may contribute to foam degradation. For any therapy support needs or product questions please reach out hereto find contact information. 1. Product Support: 541-598-3800. Proof of purchase may be required to take advantage of a promotion or request a repair within warranty. 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. 2. 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. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. Create a new password following the password guidelines. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. You can refuse to provide the Authorization for Collection and Use of Sensitive Information. CPAP.com does not and has never sold ozone-related cleaning products. This recall notification/field safety notice has not yet been classified by regulatory agencies. My product is not working. Do not Use, Next 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. Register your product and enjoy the benefits. Dont have one? Select your mask type and specific mask model. Click Save. We understand that any change to your therapy device can feel significant. This means you can set the Ramp Plus presusre once and there is no need to restart it each night. Register your device (s) on Philips' recall website . If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. COPYRIGHT 19992021 US EXPEDITERS, INC. ALL RIGHTS RESERVED. 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. If your product is eligible for extended warranty, first you need aMyPhilipsaccount. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. 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. You can still register your device on DreamMapper to view your therapy data. Enter the Captcha characters. 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. You can register here. For patients with an Android (Android version 7 or higher required) or Apple (iOS version 10 or higher required) mobile device, please download the DreamMapper mobile app from your respective app store. Fill out the registration form (leave Mobile Phone blank). To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). Intuitive. By design. In that case, your use of the service provided in this application through collection of sensitive information may be restricted. Not all direct-to-consumer brands offer sales and discounts, though. 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. On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. If you do not have a second device available we suggest you print out the instructions. Per the Philips Respironics recall notice: We cannot stress enough that Philips is treating this matter with the highest possible seriousness, and are dedicating significant time and resources to address this issue. This spreadsheet provides Medicare DME fee schedule information, by HCPCS code . Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. At the Login Page for DreamMapper, you can register for a new account or login with your existing Username and Password. September 02, 2021. 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. What is the safety issue with the device? To register your product, youll need to. Sharing your sleep therapy data provides them insight on how you are complying with your prescribed sleep therapy regimen. Philips Respironics Mask Selector uses no-touch. The data shared includes your usage of the device, mask leak measurements, CPAP pressure and your periodic breathing rate. Please know that your health and safety is our main priority, as we work through this process. 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. 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 makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. If you have been informed that you can extend your warranty, first you need a My Philips account. In summary, the CPAP/APAP/BiPAP machine supply was already tight and shrinking before the recall was announced. The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. Below youll find a list of commonly asked questions about the CPAP recall. This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. If you are considering purchasing a new machine to replace your Philips Respironics device, you must have a current prescription. To register your product, youll need to log in to your My Philips account. Note: Please use the same email address you used when registering your device for the voluntary recall. This could affect the prescribed therapy and may void the warranty. We know that you are eager to find out when youll receive your replacement CPAP, BiPAP or Mechanical Ventilator device. Then you can register your product. Keep in mind that the CPAP recall is an ongoing situation, so information from your health insurance provider or Medicare may change. If you already have a DreamMapper account but do not remember your Username, please note that your Username is your email address. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. Philips Respironics guidance for healthcare providers and patients remains unchanged. Please contact your Philips representative if you are in need of a loaner Trilogy Evo device for a patient. Countries where the receiving parties are located:Japan, Europe, etc. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. You can prevent Flurrys and Philips' collection and use of data (cookies and IP address) if you opt-out after you close this screen. 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. We know how important it is to feel confident that your therapy device is safe to use. Per Philips Respironics, possible health risks include exposure to degraded sound abatement foam and exposure to chemical emissions from the foam material. 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. Receiving party (contact information):Affiliates other than KoninklijkePhilips N.V.(contact information of responsible division:privacy@philips.com) 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 . Purpose of Collection and Use of Personal Information Select country / language; Breathe easier, sleep more naturally . Heres How to Get Low-Cost or Free CPAP Supplies! Your individual coverage with Medicare or Medicaid will determine how to proceed with your device. What information do I need to provide to register a product? December 2022 update on completed testing for first-generation DreamStation devices, Jan Kimpen, Chief Medical Officer, discusses what the test results mean for healthcare providers and their patients, Jan Bennik, Head of Test and Research Program, explains the details behind the testing results. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Register your purchase to unlock the benefits, 1. Purpose of Collection and Use of Sensitive Information In the article, Dr. Barone discusses the risks of abruptly ending treatment versus using a recalled device. 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. 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. The issue is with the foam in the device that is used to reduce sound and vibration. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. Method of provision:Electronically transfer immediately upon authorization for collection and use of personal information We thank you for your patience as we work to restore your trust. We are happy to review your prescription if youre unsure of its status. In some cases, this foam showed signs of degradation (damage) and chemical emissions. 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. Once set, the device will automatically start at the selected Ramp Plus pressure with all future therapy sessions. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Once the purpose of use is achieved, your personal information will be destroyed immediately, unless otherwise required by laws. The recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). You are about to visit the Philips USA website. Auto CPAP Advanced. 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. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. Have your DreamStation device serial number available (begins with the letter J and is 13 characters in length). (, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. Enter the captcha characters. Philips Respironics will continue with the remediation program. 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. 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. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) Next Further testing and analysis is ongoing. 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. Using a new account on a desktop or laptop. Login with your Username and new Password. To register your product, youll need to log into your MyPhilips account. Doing this could affect the prescribed therapy and may void the warranty. A patient no longer needs to tap a Ramp button every night to start at the desired pressure. 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. You are about to visit the Philips USA website. Why do I need to upload a proof of purchase? To improve treatment adherence by analyzing information of patient's CPAP use and delivering the analysis results to the patient Select your mask type and specific mask model. Agree We recommend you upload your proof of purchase, so you always have it in case you need it. Koninklijke Philips N.V., 2004 - 2023. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 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. 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. We have developed a comprehensive plan to replace the current sound abatement foam with a new material that is not affected by this issue and have already begun this process. After youve registered your machine with Philips, you may be asking, what are my options for continuing therapy while I wait for Philips to send me a replacement machine or repair kit? 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. This means you can set the Ramp Plus presusre once and there is no need to restart it each night. We are advocating on your behalf to get quicker updates and more information about the situation as it evolves. This is not our choice or our preference. 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. Access all your product information in one place (orders, subscriptions, etc. In the event of exposure to degraded foam: In the event of exposure to chemical emissions: Yes. 1875 Buckhorn Gate, 5th Floor, Mississauga, Ontario L4W 5P1. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. The DreamStation 2 CPAP Advanced is designed to provide a simplified user experience, including a premium color touchscreen with fewer panes to navigate. Dont have one? This is a potential risk to health. We have notified all customers affected by the recall through email and each customer will shortly receive a physical mailed notice. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. Learn more about the full recall process here. 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. 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 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.
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