Trilogy Evo O2 and Trilogy Evo Portable Ventilators

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.

Reason / Defects: 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. Hazards: 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) What to do: Philips will be releasing a software correction for this issue. Philips will be contacting customers when the software is released. In the interim, customers are advised to refer to the steps provided in the Customer Letter (supplied to impacted users by Philips) until the updated software is installed on the device. Infant/Pediatric EFS Calibration Pressure Increase If you are using the infant/pediatric EFS, do not perform a manual circuit calibration. Instead, use the default calibration. The pressure increase will not occur if the default circuit calibration is used. Pressure Drift (Continuous Usage) If a pressure drift is detected, the decision to reset the device and return to its original, intended settings MUST be made in consultation with a clinician. Take steps to support the patient during a brief interruption in therapy, as needed. For further information, consumers should contact Philips Customer Care Centre by phone on 1800 251 400.

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)