OECDReference EN/AU/PS1094446
Trilogy Evo O2 and Trilogy Evo Portable Ventilators
Official information organised for easier consultation. The source publication remains authoritative.
Identification
Product identification
- Product
- Trilogy Evo O2 and Trilogy Evo Portable Ventilators
Official information
Risk and measures
- Risk or hazard
- 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. 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)
- Recommendations
- 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.
Official information
Economic operators
- Manufacturer
- Philips Electronics Australia Ltd
Territory
Geography
- Distribution
- Retirada en Australia
- Country of recall
- Australia
Provenance and context
NagameAlert distinguishes content published by the source from its organisation and normalisation. Values marked “NagameAlert” belong to that processing layer. Always check measures, scope and updates in the official publication.