Philips Dreamstation 1

[Blanche Bunnell]

InJune 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only).

As the remediation of the ventilator devices continues, Philips Respironics will be communicating with Durable Medical Equipment providers (DMEs) directly throughout the process. If you are a patient or caregiver with an affected Philips Respironics ventilation device, you do not need to take any action. All ventilation remediation will be handled via your DME.

Philips has reached an agreement, subject to final Court approval, to resolve all economic loss claims brought by private plaintiffs in the United States related to the Philips Respironics voluntary recall of certain sleep and respiratory care devices.

The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. This was initially identified as a potential risk to health. After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets.

Recent testing and analyses for the first-generation DreamStation, System One and DreamStation Go sleep therapy devices indicate that the volatile organic compounds and particulate matter emissions related to foam degradation are within applicable safety limits and are unlikely to result in appreciable harm to health in patients. However, Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. Testing and analysis related to the affected ventilators is ongoing. You can find the latest testing results here.

Recent testing and analyses for the first-generation DreamStation, System One and DreamStation Go sleep therapy devices indicate that the volatile organic compounds and particulate matter emissions related to foam degradation are within applicable safety limits and are unlikely to result in appreciable harm to health in patients. However, Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. Testing and analysis related to the affected ventilators is ongoing. You can find the latest testing results here.

If you registered an affected CPAP / BiPAP device and are still waiting for your replacement, it is likely because we need important information or consent from you. Without this information, we are unable to ship your replacement CPAP / BiPAP device. Depending on your affected registered device, you may have alternative options. Please check the Patient Portal to determine if we are awaiting information from you.

The potential issue is with the foam in the device that is used to reduce sound and vibration. In some cases, this foam showed signs of degradation (damage) and chemical emissions. This is a potential risk to health.

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). As a result, testing and assessments have been carried out.

We know how important it is to feel confident that your therapy device is safe to use. 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*. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them.

Silicone foam is commonly used across the CPAP industry. This silicone foam has met all applicable industry testing standards, including particulate and VOC emissions testing, and is authorized as part of our remediation. In addition, it has been extensively tested for Philips Respironics by multiple independent, certified laboratories in accordance with the applicable regulatory standards, and no safety issues have been identified. Philips Respironics is in discussions with the FDA on the details of further testing.

When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. 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.

If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. This could affect the prescribed therapy and may void the warranty.

*Trilogy Evo devices provided as loaners do not contain the silicone foam or the affected PE-PUR foam.

The DreamStation 2 CPAP Advanced is designed to provide a simplified user experience, including a premium color touchscreen with fewer panes to navigate. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. 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. Once set, the device will automatically start at the selected Ramp Plus pressure with all future therapy sessions. A patient no longer needs to tap a Ramp button every night to start at the desired pressure. This means you can set the Ramp Plus presusre once and there is no need to restart it each night. Even Auto ON is enabled so that all you have to do is put your mask on and start breathing.

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 review the DreamStation 2 Setup and Use video for help on getting started.

After you have registered your affected device, we will confirm your information by email prior to shipment and prepare to send your replacement. We appreciate your cooperation and patience and encourage you to save your registration confirmation number for future communications. To check the status of your replacement CPAP or BiPAP device, please be sure to visit the Patient Portal.

When you receive your replacement device, please first be sure to review all written instructions for setup, cleaning of existing components, and return instructions. Also, be sure to keep all packaging materials, as they will be used to return your affected device back to Philips Respironics.

You can then start to reassemble your replacement device with the accessories you had been using, or new accessories. Once all accessories have been installed, plug in your device to a working wall outlet and wait five minutes for your device settings to upload. After five minutes, press the therapy button to initiate air flow. Your prescription pressure should be delivered at this time.

With your replacement device reassembled and ready for use, return your affected device by placing it into the cardboard package in which you received your replacement device. Using packing tape supplied, close your box, and seal it. Affix the pre-paid postage label to the box and schedule a pick up at your local FedEx. Philips Respironics has pre-paid all shipping charges.

As part of our commitment to quality and patient safety, Philips Respironics is dedicated to removing product containing the affected sound abatement foam from the market. By returning your original device, you can help to make sure that it can be repaired for future use by another patient. We appreciate your cooperation in this effort, and if you have any questions, please contact us at +1-833-262-1871.

Owners or users of DreamStation 1 devices who wish to preserve their units for purposes of a lawsuit have the option of requesting preservation, either by Philips Respironics or by the user, through the Preservation Registry established by Philips Respironics. More information and instructions on how to register for preservation may be found at:

Patients are advised to log into the Patient Portal to view approximate shipping timeframe of their replacement device. If you registered an affected CPAP / BiPAP device and are still waiting for your replacement, it is likely because we need important information or consent from you. Without this information, we are unable to ship your replacement CPAP / BiPAP device. Depending on your affected registered device, you may have alternative options. Please check the Patient Portal to determine if we are awaiting information from you.

Devices affected by the recall / field safety notice must be serviced only by qualified technicians. They do not include user serviceable parts. Attempts to remove or change the sound abatement foam may render the device permanently inoperative and create health hazards.

Please continue to follow the recall / field safety notice instructions you have received for affected Philips Respironics Sleep & Respiratory Care devices. The latest information regarding this action can be found at our publicly available web site: -update

We are producing and shipping similar CPAP, BiLevel PAP and Mechanical Ventilator platforms with a different design. 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 different, silicone foam.

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