FDA Recalls Philips Respirators
On December 22, 2022 the U.S. Food and Drug Administration (FDA) announced the Class I recall of reworked Philips Respironics Trilogy 100 and Trilogy 200 ventilators. A Class I recall is the FDA’s most serious recall, indicating devices create a heightened risk of serious injury or death.
Trilogy ventilators are intended to control or assist patient breathing by delivering a predetermined percentage of oxygen per breath. Used in both homes and health care facilities, by both pediatric and adult patients, Trilogy ventilators have sold broadly: Philips has distributed 13,811 in the U.S., as well as 7,544 overseas.
Philips has had a series of issues with its respiratory products in recent years. These Philips Trilogy 100 and Trilogy 200 ventilators were originally recalled in June 2021, as part of a broader recall. The original recall, which included ventilators, BiPAP machines, and CPAP machines, raised issues with health risks caused by sound abatement foam breakdown. The polyester-based polyurethane (PE-PUR) used in many Philips devices breaks down over time, potentially releasing harmful debris and chemicals into a user’s airflow. Philips proposed to replace the polyurethane foam with a silicone-based alternative.
On August 17, 2022, the FDA reported an acceleration of reports that PE-PUR was breaking down and causing risk. The FDA noted over 69,000 MDRs, including 168 reports of death. Philips indicated at the time that it was about halfway through its recall of devices in the U.S. On December 22, 2022, the FDA proposed
The FDA’s December 2022 issues are:
- The silicone sound abatement foam, installed as replacement for PE-PUR foam, may separate from the backing due to adhesive failure, blocking the airpath. This could cause asphyxia, hypoventilation or hypoxemia, potentially life threatening breathing issues.
- Some residual PE‐PUR sound abatement foam was found in reworked Trilogy 100 and Trilogy 200 ventilators. This was not the first recall for finding PE-PUR: in January 2022, Philips was required to recall its Trilogy EVO ventilators because a supplier used PE-PUR foam in error, after PE-PUR was banned.
As a result of the recall, Philips has temporarily paused the reworking process for the Trilogy ventilators. The FDA has recommended that providers transition ventilator-dependent patients to alternative ventilators.
Philips has also recalled multiple devices for issues not associated with the PE-PUR Foam. On August 2, 2022, Philips announced a Class I recall of certain Amara masks because their magnetic headgear clips could seriously injure a patient with a metallic medical device or metallic object in the body. On June 3, 2022, the FDA announced that Philips Respironics would recall all V60 and V60 Plus ventilators because internal power fluctuation could cause the ventilator to shut down, possibly without any alarm or warning.
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