UPDATE: In January 2023, the FDA classified this recall as a Class I recall, the most serious type of recall.
Date Issued: December 22, 2022
The U.S. Food and Drug Administration (FDA) is providing additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. These Philips Trilogy 100 and Trilogy 200 ventilators were recalled in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. The two recent issues are:
- The silicone sound abatement foam, installed to replace the PE-PUR foam, may separate from the plastic backing due to adhesive failure. The silicone foam material may potentially move and block the airpath, which may reduce air flow in the ventilator and could also cause the device to alarm. If an alarm is not recognized or acted upon, the patient could experience trouble breathing, such as asphyxia, hypoventilation, or hypoxemia, which can be life threatening. BiPAP and CPAP machines reworked or replaced due to the recall in June 2021 are not affected by this silicone foam adhesion failure. Adhesive is not used to hold the silicone foam in place in the reworked or replaced BiPAP and CPAP machines.
- Additionally, Philips observed residual PE‐PUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. Further exposure to PE-PUR foam may cause potential health risks, which can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users. Preliminary results show PE-PUR and environmental debris in some samples.
Philips has temporarily paused reworking the Trilogy 100 and Trilogy 200 ventilators. Philips distributed 13,811 in the U.S. and 7,544 outside of the U.S. reworked Trilogy ventilators impacted by this recall. While the FDA is aware of complaints received from Philips' customers outside of the U.S., the FDA is not aware of any injuries or deaths associated with this recall in the U.S.
Trilogy ventilators are used to provide breathing assistance to both pediatric and adult patients. A ventilator is intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen. Trilogy ventilators are intended to be used in homes and health care settings, including when patients may be using a wheelchair or gurney.
Each Trilogy 100 and Trilogy 200 ventilator is identified by serial number, which is located on the bottom of the device.
Recommendations for People Who Use Recalled Ventilators at Home
- Do not stop or change ventilator use until you have talked with your health care provider.
Recommendations for In-Home Caregivers, Health Care Providers, and Health Care Facilities
- Consider transitioning ventilator-dependent patients to an alternative life-support ventilator, as determined by clinical assessment.
- Review these recommendations with patients who use the recalled ventilators, including that for some patients, stopping use of the ventilator may involve greater risk than continuing to use the recalled ventilator.
- Ensure backup monitoring is configured as required by the clinical assessment.
- Consider monitoring heart rate, blood pressure, respiratory rate, pulse oximetry measurements, and electrocardiogram readings, which may provide additional advanced warning and lead to faster intervention if breathing problems occur. Ensure you know how to use these medical devices if they are recommended.
- Ensure the ventilator alarm settings are configured appropriately for the patient's need, with special consideration for the alarms listed below.
- Ensure alternative ventilation equipment is available, such as a manual resuscitator, as appropriate to the patient's need, in case of emergency issues with alarms that cannot be resolved.
- The following alarms could be triggered if the silicone foam separates from the airpath:
- Low Inspiratory Pressure
- Low Minute Volume
- High Temperature
- Check Circuit
- Low Circuit Leak
- If alarms occur, investigate the source of the alarm, including those listed above. If the situation cannot be resolved, exchange for a back‐up ventilator.
- Consider using an inline bacterial filter, which may help to filter out pieces of PE-PUR foam. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. The FDA's evaluation of the information provided by Philips is ongoing. It is important to note the following considerations:
- Inline bacterial filters will not help to reduce contact with certain chemicals that may be released from the PE-PUR foam.
- Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately.
- If a ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems.
- Quarantine all impacted ventilators that are removed from service and indicate which serial numbers removed from service need to be exchanged for an alternative device.
- Contact Philips Customer Service at 1-800-345-6443 or visit their website at www.usa.philips.com for more information about alternative devices, such as the Trilogy Evo ventilator, or for any other support concerning this issue if needed.
Reporting Problems with Your Device
If you think you have a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form or call 1-800-332-1088 for more information on how to mail or fax the form.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
The FDA is assessing the potential health risks presented by use of the reworked ventilators with the silicone sound abatement foam, reviewing the strategy the company proposes to address the problem, and may take additional actions as appropriate. For more information about the FDA's actions related to the recalled devices in June 2021, see the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls.
The FDA will keep the public informed if significant new information becomes available.
If you need any further information or support concerning this issue, please contact your local Philips representative or Philips Customer Service at 1-800-345-6443 or visit Philips Information for Patients.
Find more information on medical device recalls at What is a Medical Device Recall? | FDA.
For general questions, email the Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov or call 800-638-2041 or 301-796-7100.