The information is being updated on a regular basis and answered based on the latest safety communications from the FDA. 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. Sharing your sleep therapy data provides them insight on how you are complying with your prescribed sleep therapy regimen. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. 1. Select country / language; Breathe easier, sleep more naturally . Are there any recall updates regarding patient safety? It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. Register your product and start enjoying benefits right away. We know that you are eager to find out when youll receive your replacement CPAP, BiPAP or Mechanical Ventilator device. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. There are many reasons people choose to purchase a CPAP machine outright, even if you have health insurance. The recall is for all Philips Respironics CPAP/BiPAP units (excluding the new Dreamstation 2 unit). 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. 2. 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. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. We are advocating on your behalf to get quicker updates and more information about the situation as it evolves. Click Return to Login after successful password reset. Select your mask type and specific mask model. You are about to visit the Philips USA website. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. Register your child's device on the recall website or call (877) 907-7508 for assistance. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Using alternative treatments for sleep apnea. Your individual coverage with Medicare or Medicaid will determine how to proceed with your device. As a result, testing and assessments have been carried out. To improve treatment adherence by analyzing information of patient's CPAP use and delivering the analysis results to the patient By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. We are happy to review your prescription if youre unsure of its status. Since the news broke, customers have let us know they are frustrated and concerned. 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. Auto CPAP Advanced. Last year the FDA issued a safety communication about PAP cleaners. The devices included are CPAP machines due to issues related to the polyester-based polyurethane sound abatement foam used in its continuous and non-continuous ventilators. We also offer frequent discounts on our machines, masks, and other CPAP accessories, which can help you save money on the equipment you need. We strongly recommend that customers and patients do not use ozone-related cleaning products. CPAP.com is a family-owned and operated business dedicated to providing affordable sleep apnea equipment to those who need sleep therapy. Duration of Retention and Use of Personal Information After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. FDA Green Lights Repair and Replacement Program for Philips DreamStation Recall, How do I know if my device was recalled?, a process he said would likely take a year, helpful guide to finding a low-cost CPAP machine. If you do not have a second device available we suggest you print out the instructions. 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. When you provide the authorization for collection and use of personal information below, you will be informed of various information about recent news and events via text message or email. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. You can log in or create one. View/download instructions for desktop and laptop, Using an existing account on a desktop or laptop. Mandatory items: Time of device use as per the patient's use, prescribed pressure, degree of mask leak, and periodic breathing rate Agree Intuitive. A patient no longer needs to tap a Ramp button every night to start at the desired pressure. We created this helpful guide to finding a low-cost CPAP machine if you cant afford to purchase a new machine. For more information about how DreamMapper processes your data click 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. 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. Select your mask type and specific mask model. In some cases, this foam showed signs of degradation (damage) and chemical emissions. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. If you do not remember your DreamMapper password or need to reset it: Click Forgot your password?. Further testing and analysis is ongoing. Create a new password following the password guidelines. Koninklijke Philips N.V., 2004 - 2023. 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). The company anticipates the rework to begin this month. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. 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 . Items of Personal Information to be Collected All rights reserved. Cant Afford a New CPAP Machine? Whether you choose to buy a machine outright or through your insurance company or pursue options through a government assistance program or donation initiative, CPAP.com is here to help you navigate the CPAP recall. You can log in or create one here. You are about to visit the Philips USA website. For further information about the Company's collection and use of personal information, please click the URL below. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Koninklijke Philips N.V., 2004 - 2023. DreamMapper has the ability to share your therapy data with your Home Care Providers electronic health records system. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). 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. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Register your purchase to unlock the benefits, 1. You are about to visit the Philips USA website. We understand that any change to your therapy device can feel significant. If you had a CPAP machine before you got Medicare, you will need to check with Medicare to see if you qualify for certain requirements that will cover the cost of the replacement of your machine. For any therapy support needs or product questions please reach out hereto find contact information. Please be assured that we are treating this matter extremely seriously, and are working to address this issue as efficiently and thoroughly as possible. 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. Using a new account on a desktop or laptop. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. Click Submit to create your account. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. How can I register my product for an extended warranty? If the product does not perform after following the FAQs & troubleshooting steps. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. 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. By design. Philips DreamStation 2 . Patient setup and training. Countries where the receiving parties are located:Japan, Europe, etc. 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. All of the relationships we hold dear, our family, friends, coworkers, and customers are affected. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. 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. Please check our online troubleshooting and FAQs to find solutions for the most common issues, Kindly contact with our consumer support team by the following this link. What devices have you already begun to repair/replace? If your product is eligible for extended warranty, first you need aMyPhilipsaccount. In that case, your use of the service provided in this application through collection of sensitive information may be restricted. Purpose of Collection and Use of Sensitive Information You can refuse to provide the Authorization for Collection and Use of Personal Information. 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. 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 . Register your product and enjoy the benefits. You can also upload your proof of purchase, so you have it, if you need it for service or repairs. Further testing and analysis is ongoing. 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. 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. The FDA is still considering the data and analyses that Philips Respironics has provided and may reach different conclusions. is designed . 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. We will continue to provide regular updates to you through monthly emails. IMPORTANT: If a humidifier was included with your sleep therapy device, be sure to remove the water chamber before you proceed. 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%). 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. 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. Connect your DreamStation Your DreamStation has built-in support for Bluetooth which will connect to your mobile device and transfer your therapy results. 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? 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*. Access all your product information in one place (orders, subscriptions, etc. We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. 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). You can sign up here. All rights reserved. What can I do with a My Philips account? Proof of purchase may be required to take advantage of a promotion or request a repair within warranty. 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. Don't have one? High heat and high humidity environments as well as unapproved cleaning methods such as ozone, may also contribute to foam degradation. What is the advice for patients and customers? Have the product at hand when registering as you will need to provide the model number. You can refuse to provide the Authorization for Collection and Use of Personal Information. 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. If you do not have a second device available we suggest you print out the instructions. Log in Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Per Philips Respironics, possible health risks include exposure to degraded sound abatement foam and exposure to chemical emissions from the foam material.