Philips Respironics Sleep and Respiratory Care devices

• The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices.
• The affected products are identified in the tables below:

We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. Please be assured that our teams are working on a comprehensive remediation program to support patients with an affected device. As a first step, if your device is affected, please start the registration process here.

• The 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.
• It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. 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.  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. Further testing and analysis is ongoing. 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.

• 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.
• This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation.
• 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.

• We understand that any change to your therapy device can feel significant. 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.
• 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.
• 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.

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.

Before opening your replacement device package, unplug your affected device and disconnect all accessories. Be sure to place your mask, tubing and SD card aside as they may be used with your replacement device. 

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: https://www.mdl3014preservationregistry.com .

Philips Respironics continues to ship remediated devices and has increased production capacity to address the recall. We expect to continue to ship replacement devices throughout the remainder of 2022.

It is important that you do not stop using your device without discussing with your doctor. Although you may feel anxious at the news of the recall, we encourage you to talk to your doctor about the right treatment for you. Please refer to the FDA’s guidance on continued use of affected devices.

We expect that we will have completed the repair and replacement program by the end of 2022 for the vast majority of patients. 

Please be assured that we are doing all we can to meet demand, including increasing the production of repair kits and replacement devices. We will share regular updates with all those who have registered a device. 

No. These “repair kits” are not approved for use with Philips Respironics devices. They are not approved for use by the FDA. They are not manufactured by Philips Respironics or our partners, and may pose a health hazard if used.

As part of the remediation, we are offering repair or replacement of affected devices free of charge. We do not offer repair kits for sale, nor would we authorize third parties to do so.

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: https://www.philips.com/src-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.

We ask that patients return their affected units as part of the repair and replacement program related to the recall / field safety notice. 

If a user has elected to preserve his/her unit and has provided the required information in the Preservation Registry at https://www.mdl3014preservationregistry.com, Philips will not charge the user’s DME supplier for the cost of the replacement device.  However, if the user is not in the Preservation Registry and fails to return his or her unit, then Philips may charge the user’s DME supplier for the cost of the replacement device. 

As soon as we receive the device, we replace the sound abatement foam and associated air pathway blower with brand new parts. This replacement reinstates the two-year warranty. 

We then thoroughly clean and decontaminate the device, update the firmware, test, and repackage it with a “recertified” sticker to show that it is ready for use. As part of our commitment to quality and patient safety, Philips 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. 

No- the replacement device you have received is not affected by the recall/ field safety notice, because the foam in the device has been replaced with a new type of foam. During the recertification process for replacement devices, we do not change the device serial number or model number.

Only devices affected by the recall/ field safety notice must be registered with Philips. You do not need to register your replacement device.

Please contact Patient Recall Support Team (833-262-1871). They can help you if you have questions about how to use your replacement device and can troubleshoot and document issues you may be having.

Based on our analysis, the root cause of this issue is related to the sound abatement foam, currently used to reduce noise and vibration in specific identified products of the Sleep & Respiratory Care portfolio.

• We expect that we will have completed the repair and replacement program in the US by approximately the end of 2022 for the vast majority of patients.
• We understand that this is frustrating and concerning for patients. Please be assured that we are doing all we can to meet demand, including increasing the production of repair kits and replacement devices. We will share regular updates with all those who have registered a device. 

• Preventive maintenance for Trilogy has been paused until the new silicone foam is authorized and available.
• The Trilogy, as well as the components containing PE-PUR foam, have all been placed on hold, for potential risks as outlined in the sound abatement foam recall 1) PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and 2) the PE-PUR foam may off-gas certain chemicals.
• Trilogy service instructions require PM periods as outlined for the 24 months/10,000 blower hours as well as the blower replacement.  During these preventative maintenance periods, the service requires replacement of the PE-PUR foam components. Therefore, PM service cannot be completed until we have authorization for the new foam design with Trilogy.
• 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 contact your Philips rep if you are in need of a loaner Trilogy Evo device for a patient. 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.

We are not taking new orders at this time, and we have stopped all new shipments temporarily, in order to support the field safety notice.

• Spare parts are not currently affected by the ship hold, though there may be some limited exceptions.
• For example, spare parts that include the sound abatement foam are on hold.

We estimate that between 3 and 4 million patients are affected, half of whom are in the U.S.

• The 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.

• Examples of potential risks include exposure to degraded sound abatement foam particles or exposure to chemical emissions from the sound abatement form material.
• Our quality management system processes and analyis of user reports have indicated that this material may lead to patient harm and impact clinical care.
• While there have been limited reports of headache, upper airway irritation, cough, chest pressure and sinus infection that may have been associated with the foam, based on lab testing and evaluations, it may be possible that these potential health risks could result in a wide range of potential patient impact. These could include transient potential injuries, symptoms and complications, as well as possibly serious injury which can be life-threatening or cause permanent impairment, or require medical intervention to preclude permanent impairment.

To resolve this situation as quickly as we can, we are doing the following:

• Patients who are concerned should check to see if their device is affected. The list of affected devices can be found here.
  
• If their device is affected, they should start the registration process here. All patients who register their details will be provided with regular updates.
  
• We also remind 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.