Trilogy Evo O2 and Trilogy Evo Portable Ventilators
Published 8 October 2021
Product
Trilogy Evo O2 and Trilogy Evo Product codes: IN2100X15B and IN2110X15B Multiple serial numbers (see attached serial number list) ARTG 332200 (Philips Electronics Australia Ltd - Portable ventilator, electric)
Why it was recalled
Two software issues have been identified that relate to a pressure increase in the ventilators. 1. Infant/Pediatric External Flow Sensor (EFS) Calibration Pressure increase. An increase in the expiratory pressure (EPAP/PEEP) can occur when the paediatric/infant External Flow Sensor is used with an Active Flow or Dual Limb circuit and a manual circuit calibration is performed. 2. Pressure Drift (Continuous Usage). When a Trilogy Evo or Trilogy Evo O2 model is used continuously without any interruption to therapy, the baseline pressure may increase or decrease.
Hazard
1. Infant/Pediatric EFS Calibration Pressure Increase Potential for inappropriate therapy to be provided when the EFS is used with manual calibration, increasing the risk of serious health complications including: - Barotrauma (an injury to the lungs because of too much pressure) - Hypotension (a decrease in blood pressure) - Hypercarbia (too much carbon dioxide in the blood) 2. Issue 2 – Pressure Drift (Continuous Usage) Potential for inappropriate therapy to be provided to a patient if there is a pressure increase or decrease from the baseline pressure settings without alarm, increasing the risk of serious health complications including: - Barotrauma (an injury to the lungs because of too much pressure) - Hypotension (a decrease in blood pressure) - Dyspnea (a sensation of shortness of breath) - Hypoxemia (a low amount of oxygen in the blood)
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.