The U.S. FDA is providing additional information to patients, caregivers, and healthcare providers about two recent issues in certain reworked Philips Respironics 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.
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.
One of the new issues mentioned is related to the silicone sound abatement foam—which was installed to replace the PE-PUR foam—which 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, the FDA says.
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.
