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. On behalf of Philips, Apptentive will use information about your device (such as manufacturer, model, and operating system), app usage patterns, and information you elect to provide (such as survey responses or feedback) to provide services to Philips to help them understand App usage, provide support, and improve their products and services. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. Enter your Username and affected Device Serial number. If you already have a DreamMapper account but do not remember your Username, please note that your Username is your email address. 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. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. DreamMapper is part of the Dream Family from Philips Respironics. 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. DreamMapper has the ability to share your therapy data with your Home Care Providers electronic health records system. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. 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. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. Please visit mydreammapper.com by clicking the Login button above. Please click either Yes or No. 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. Register your product and enjoy the benefits. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. Even Auto ON is enabled so that all you have to do is put your mask on and start breathing. Enter the captcha characters. As new information and options become available to help our customers we will switch our operations accordingly. Items of Sensitive Information to be Collected Philips reports that, "The potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects." Philips reports that the foam-related complaint rate in 2020 was low (0.03%). Please review the attached. After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. 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. Log in Call1.800.356.5221M-F 8AM-8PM | Sa 8AM-5PM (CST). 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. 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. Register your product and start enjoying benefits right away. 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. Product Support: 541-598-3800. Enter your Username and affected Device Serial number. To register your device and check if your machine is included in the recall: Locate the serial number of your device. The recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). You can log in or create one. 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. To register your product, you'll need to log into your MyPhilips account. 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 . We have completed all requests by Philips Respironics and we eagerly await a plan that will allow us to provide actionable solutions to customers. Confirm the new password in the Confirm Password field. September 02, 2021. 1. We recommend you upload your proof of purchase, so you always have it in case you need it. 1. We stand by, ready to help Philips Respironics technologically or logistically if needed to quicken getting help to our customers. Do not Use, Next 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. Register your product and start enjoying benefits right away. Receiving party's purpose of use of personal information: Store the collected information You can sign up here. 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. This is not our choice or our preference. 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. What devices have you already begun to repair/replace? Still, buying a new CPAP machine through insurance is the best option for some. 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. Please contact your Philips representative if you are in need of a loaner Trilogy Evo device for a patient. Items of Personal Information to be Collected For more information on the recall notification (U.S. only) / field safety notice (Outside of U.S.), as well as instructions for customers, users and clinicians, affected parties may contact their local Philips representative or visit. Further testing and analysis is ongoing. Proof of purchase may be required to take advantage of a promotion or request a repair within warranty. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. 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. 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. 1. If your product is eligible for extended warranty, first you need aMyPhilipsaccount. This is a realistic look at what you can expect when removing the Foam from your recalled Philips DreamStation 1. 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. Login with your Username and new Password. 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. To confirm that your Philips PAP device has been recalled, you need to visit the Philips registration site to register your device. Proof of purchase is a printed receipt from the shopwhere you purchased your product, or a PDF invoice from an online retailer. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Click Return to Login after successful password reset. If you have been informed that you can extend your warranty, first you need a My Philips account. 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! Simplified. If you do not have a second device available we suggest you print out the instructions. Flurry will not associate your IP address with any other data held by Flurry. You are about to visit a Philips global content page. 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. Enter your Username and Password and click Login. If youre considering purchasing a machine outright and are a long-time user of the DreamStation, we encourage you to check out this article to see how the ResMed AirSense 10 stacks up against the currently-recalled DreamStation from Philips Respironics. 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 . A patient no longer needs to tap a Ramp button every night to start at the desired pressure. Register your device (s) on Philips Respironics' recall website to stay informed of updates from Philips Respironics regarding any new instructions or other corrective fixes, which the. 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. We have notified all customers affected by the recall through email and each customer will shortly receive a physical mailed notice. Amsterdam, the Netherlands - Following the company update on April 26, 2021, Royal Philips (NYSE: PHG; AEX: PHIA) today provides an update on the recall notification* for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address identified . Have the product at hand when registering as you will need to provide the model number. 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. 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. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. You can also upload your proof of purchase, so you have it, if you need it for service or repairs. We learned of this recall at the same time as our customers and have been in daily communication with Philips Respironics since that time. Optional item: Mobile phone number 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. If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. Koninklijke Philips N.V., 2004 - 2023. Below youll find a list of commonly asked questions about the CPAP recall. The affected products are identified in the tables below: All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers, DreamStation ASV DreamStation ST, AVAPS SystemOne ASV4 C-Series ASV C-Series S/T and AVAPS OmniLab Advanced+, SystemOne (Q-Series) DreamStation DreamStation Go Dorma 400 Dorma 500 REMstar SE Auto, Trilogy 100 Trilogy 200 Garbin Plus, Aeris, LifeVent, A-Series BiPAP Hybrid A30 (not marketed in US) A-Series BiPAP V30 Auto, A-Series BiPAP A40 (not marketed in the US) A-Series BiPAP A30 (not marketed in the US). Further testing and analysis is ongoing. 1. To register your product, youll need to log in to your My Philips account. Philips Respironics will continue with the remediation program. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. 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. Create New Account Fill out the registration form. Sharing your sleep therapy data provides them insight on how you are complying with your prescribed sleep therapy regimen. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. All oxygen concentrators, respiratory drug delivery products, airway clearance products. 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. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. 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. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) How it works. 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. As we learn more, we will update our customers via email and the CPAP community at large using this blog. 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. We encourage you to read it if youre experiencing hardship during this recall. The company intends to complete its repair and replacement programs within approximately 12 months. Additionally, Philips Respironics suggests patients review the age of their devices, as they are typically recommended to be replaced after five years of use. If you continue using your device, please note that ozone is referenced by Philips Respironics as a potential contributing factor to degraded foam. Once the purpose of use is achieved, your personal information will be destroyed immediately, unless otherwise required by laws. Click Register. Shop now Item # DSX520H11C Not currently in stock Dreamstation 2 Auto CPAP with Humidifier Overview 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. Your patients may receive a DreamStation 2 as a replacement for their affected CPAP device. If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. Then you can register your product. Since CPAP.com does not bill insurance or accept Medicare, we are able to offer you the lowest priced machines. We strongly recommend that customers and patients do not use ozone-related cleaning products. Selected products 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. In many cases when a product doesnt perform as you would expect, the problem can be resolved at home through basic troubleshooting. Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. 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. Philips has established a registration process where you can look up your device serial number and begin a claim if your . 1875 Buckhorn Gate, 5th Floor, Mississauga, Ontario L4W 5P1. 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. Register your child's device on the recall website or call (877) 907-7508 for assistance. We will continue to take any actions Philips Respironics or the organizations governing them approve relating to this recall as quickly as we are able to execute them. It also will guide you through the registration process. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Mandatory items: Time of device use as per the patient's use, prescribed pressure, degree of mask leak, and periodic breathing rate 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. 283% This App uses Flurry Analytics, an analytics service (Flurry Analytics) provided by Yahoo Inc. Register your product and enjoy the benefits. If you cant afford a new machine outright or are having issues with your insurance provider, rest assured that there are several options that exist to find low-cost or free CPAP equipment, including government assistance or charity donation programs. You can register here. If you do not remember your DreamMapper password or need to reset it: Click Forgot your password?. This recall notification/field safety notice has not yet been classified by regulatory agencies. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. If you have any concerns we suggest you contact your durable medical equipment provider or your sleep specialist.Per Philips Respironics, all patients using one of their PAP devices should discontinue use immediately due to the health risks. Please review the DreamStation 2 Setup and Use video for help on getting started. We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. This is a potential risk to health. 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. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. In that case, your use of the service provided in this application through collection of personal information may be restricted. This process should take about 10 minutes to complete, but may vary based on internet speed or device used. In compliance with Philips instructions and standard recall practices, CPAP.com is not replacing recalled products with current stock nor issuing refunds for past orders. 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. To register your product, you'll need to log into you're my Philips account. Providing DreamMapper with the mask that you use for your therapy will allow us to assist you in obtaining good mask fit. You can also upload your proof of purchase, so it is stored safely if you need it for service or repair of your product. You can sign up here. Philips DreamStation 2 . 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. This approach needs to go through some regulatory hurdles first. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. 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.