Dive Brief:
- Philips Respironics has reported two injuries and one death related to a problem with its Trilogy Evo ventilators that can result in patients not receiving enough oxygen, according to a Monday notice from the Food and Drug Administration.
- Philips began the recall in March after finding the buildup of dust can block the devices’ air vents, causing them to no longer deliver the right amount of air pressure or volume.
- As a result, patients may not receive enough oxygen, and may experience a build-up of carbon dioxide, which could result in serious injury or death, the FDA said in its recall notice.
Dive Insight:
Philips’ Trilogy Evo ventilators are used as breathing support for people who need mechanical ventilation in hospitals, during patient transport and in homes. The recall includes 73,000 devices.
Philips spokesperson Steve Klink wrote in an email that Philips has received three reports of patient adverse events related to the problem, including one death, which “cannot currently be attributed to this issue.” The device from that report was returned to Philips for investigation without filters installed and with severe contamination present, but it operated as intended where numerous high-priority alarms were confirmed, Klink wrote.
The affected devices can continue to be used per their instructions and an additional guidance provided in a field safety notice earlier this year.
The FDA posted that notice in June, noting that Philips is now requiring use of a particulate filter with the device, which was previously optional. The company recommended users replace the filters as indicated to prevent the devices from malfunctioning, or switch to another device if they can’t resolve the problem.
The recall is the latest in a string for Philips Respironics, which has been in the process of repairing or replacing 5.5 million sleep apnea machines and respirators due to a risk of the sound abatement foam used in the machines breaking down and being inhaled by patients.
For the Trilogy ventilators alone, the FDA posted a separate recall in April warning that a problem with an internal sensor could lead to under-delivery of oxygen. Philips said it planned to fix the issue with a software update.
Philips started another recall at the end of 2021 after finding that the polyester-polyurethane foam that was the subject of the company’s larger recall was used to make some of the Trilogy Evo ventilators.