Philips pauses remediation program for vents 

AMSTERDAM – Philips has temporarily paused its remediation program for its Trilogy 100/200 ventilators while it investigates a limited number of complaints on remediated units. 

“We anticipate a several week delay from our initial four- to six-week timeline in providing remediated devices back to our customers,” the company stated in a Nov. 7 update. “Remediating these devices in a timely manner is our top priority. In order to keep remediation progressing once our investigation is complete, please continue to return product that is currently not in use.” 

The U.S. Food and Drug Administration then announced on Nov. 17 that it had informed Philips that the Trilogy 100/200 vents that have been reworked as part of a June 2021 recall have two potential issues: 

1. The new silicone sound abatement foam, installed to replace the polyester-based polyurethane (PE-PUR) foam, may potentially separate from the plastic backing and could impact the performance of the device by potentially blocking the air inlet and thus lowering the inspiratory pressure. If the air pressure is significantly impacted, the device could issue a ventilator alarm. 
2. Trace amounts of particulate matter have been found in the air pathway of some reworked ventilators. Particulate samples were sent to a third-party lab for evaluation. Preliminary results show PE-PUR and environmental debris in some samples, and only environmental debris in others. 

The FDA has requested additional information from Philips to better understand the cause of the issues and to provide informed recommendations to patients, caregivers and health care professionals. 

Once remediation resumes, the company points customers to its “Trilogy remediation step-by-step guide.” 

Philips announced in June that it had begun remediating affected Trilogy 100/200 devices at its service centers.