In March, Philips recalled more than 73,000 ventilators that absorbed dust and dirt into breathing tubes. This week, the Food and Drug Administration reported that the issue has been associated with at least one death and two injuries.
The recall impacts Philips’ Trilogy Evo ventilators, which are used primarily in hospital settings to support breathing for pediatric and adult patients. They’re meant for people on life support, like the thousands of Covid patients who needed a machine to breathe for them. A buildup of dirt in the device’s air path could block oxygen, leading to serious injury or death.
Philips did not immediately respond to STAT’s request for comment.
Philips told affected customers in April they should look at the part number on the bottom of their devices and match them against those noted in the recall letter. The company is not sending replacements, instead urging customers to use a Philips-approved filter in order to prevent the accumulation of dust. The company also told hospital customers to closely monitor changes to therapy. If all fails, they should use different ventilators.
Philips’ respiratory machines have been plagued with a number of serious issues, the most widespread of which was the breakdown of soundproofing foam in CPAP machines. The issue left many patients at risk of inhaling the chemicals while they slept, and led to the recall of millions of CPAP machines. There have been more than 350 reports of deaths associated with that recall. Some patients, who rely on CPAP machines to treat their sleep apnea, waited over a year for replacements. The belabored recall underscored the FDA’s gaps in post-market oversight, and generated gains for Philips’ competitors.
Some Trilogy Evo ventilators also incorporated the problematic foam, and several hundred were recalled in 2021. Another 62,000 were recalled in April for a sensing problem that could lead to under-delivery of oxygen.
The string of recalls have led to a dramatic drop in trust for the medical device giant, resulting in class-action lawsuits and millions of dollars in losses.