| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00170-1 |
| Product Name/Description |
Trilogy Evo, Trilogy Evo O2, Trilogy EV300
Trilogy Evo, Australia
Part number: AU2110X15B
Trilogy Evo, O2, International
Part number: IN2100X15B
Trilogy Evo, International
Part number: IN2110X15B
Trilogy EV300, International
Part number: IN2200X15B
ARTG's 332200, 336800 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
Philips is aware of a potential safety problem with Trilogy Evo, Trilogy Evo O2, and Trilogy EV300 devices where the ventilator can issue a Battery Depleted or Loss of Power alarm while sufficient power is still available. This can result in a sudden loss of ventilation while the device alarms.
A software algorithm that calculates remaining battery life can malfunction and cause the device to either:
A. Issue a Loss of Power alarm that stops CPAP or PSV therapy while operating on battery power alone.
B. Issue a Battery Depleted alarm while continuing therapy if plugged into a permanent power source, such as AC or DC power.
This can only happen if all of the following conditions are met:
1. The device is operating in CPAP or PSV mode.
2. The device is not able to detect the respiratory effort of the patient for at least ten minutes and fifty-five seconds.
Philips Respironics has received reports of this malfunction and has observed no incidents of patient injury or harm. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Device(s) may continue to be used safely in CPAP or PSV mode if all safety measures are followed:
· Ensure the Backup Ventilation is set to ON and the apnea interval setting is correct and appropriate for clinical assessment of patient.
· Keep the device plugged into AC or DC power where possible.
· Keep an alternative form of ventilation on standby. If the device is unplugged for patient transport, plug the device back immediately upon return.
· Do not leave a patient unsupervised while operating on battery power alone.
· Follow typical monitoring protocols for ventilated patients.
· Immediately plug the device into a power source if a Loss of Power alarm occurs. If no power sources are available, then remove the detachable battery and put it back in. Each of these will clear the alarm and restart the ventilator.
Philips is developing a software fix for release in the 2nd quarter of 2024. When available, additional advice on how to access and install it will be provided. |
| Contact Information |
1800 830 517 - Philips Customer Support |