Philips Has More Respiratory Device Problems

On November 17, Philips informed the FDA its Respironics Trilogy ventilators reworked for June 2021’s recall have two new possible issues.
 
The new silicone abatement foam installed to replace the polyester-based polyurethane (PE-PUR) foam may separate from the plastic backing and could affect the device’s performance by blocking the air inlet and lowering inspiratory pressure. If the air pressure is significantly blocked the device could issue a ventilator alarm.
 
Trace amounts of particulate matter were found in the air pathway of some reworked Trilogy ventilators. These were sent to a third-party lab to be evaluated, and preliminary results show PE-PUR and environmental debris in some samples. Others only showed environmental debris.
 
Today, Philips released an update on the recall. The company said the problems only affect the Trilogy 100/200 ventilators that were already repaired from the June 2021 recall.
 
According to Philips, as of November 1 the observed occurrence rate of reportable events for the silicone foam separation was less than 0.015% of corrected Trilogy devices. Based on available information, the root cause was determined to be associated with an assembly step in inserting the silicone foam.
 
Philips Respironics expects to finish its investigation and root cause analysis of both problems before the end of November. While the investigation is underway, Philips has momentarily suspended Trilogy 100/200 repairs.

Philips also commented that the problems don’t impact any CPAP or BiPAP sleep apnea devices that have been remediated.