Philips’ Software-Related Trilogy Ventilator Recall Is Class I

Philips’ recall of Trilogy Evo, EV300, Evo O2, and Evo Universal continuous ventilators distributed between March 20, 2019 to February 16, 2024 over a possible software-related power malfunction has been deemed Class I by the U.S. Food and Drug Administration (FDA).
 
The company’s March 19 Urgent Medical Device Correction Notice notified Trilogy Evo customers to update to the latest software version (1.05.06.00) because all previous algorithms can cause the ventilators to sound a “battery depleted” or “loss of power” alarm while adequate power is still available.
 
The loss of power alarm halts assisted breathing support when the device is operating on battery power alone. The battery depleted alarm may happen during therapy if it’s plugged into a permanent power source, without stopping ventilation.
 
Philips further explained that the malfunction only happens without software version 1.05.06.00 or operating in CPAP or PSV mode. It may also occur when the ventilator can’t detect respiratory effort for at least 10 minutes, 45 seconds.
 
The company said it has not received reports of death or serious injury as of May 13.
 
The recall is a correction, not a product removal. Customers were advised in Philip’s correction notice to update immediately to the latest software, which the company is offering with no charge on MyP4P.
 
For ventilators not updated, Philips explained to make sure Backup Ventilation is on and that the apnea interval setting is correct based on patient assessment. The device should also be plugged into AC/DC power as long as possible and an alternative ventilator kept on standby.
 
Philips urged to not leave patients unsupervised while the Evo devices are operating on battery power alone and to continue to use backup vitals monitors for pulse oximetry or heart rate.

About Trilogy ventilators

The ventilators use a microprocessor-controlled blower for pressure support, pressure control, or volume control during breathing support. They’re meant to continuously or intermittently assist those needing breathing help.
 
Trilogy ventilators can be used in clinical, home, and non-emergency transport like a wheelchair, personal vehicle, or ambulance.