| TGA Action ID |
RC-2026-RN-00795-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
LUISA, TIVAN LS, Life One ventilators
Model: LM150TD
Firmware Versions: 1.15.0010 & 1.15.0018 |
| ARTG Number |
389685 |
| Unique Device Identifier (UDI) |
(01)04050384299589 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
A communication failure has been identified between the device electronics and the internal or external battery in the affected ventilators. If the communication failure occurs, the displayed battery charge level may no longer update and may remain at the last recorded value. At the same time, charging of the internal and external battery may be impaired while the device is connected to mains power. If the condition remains undetected, the battery may become fully discharged. During battery operation, or following interruption of external power, this could result in unexpected shutdown of the ventilator without prior warning.
For patients with high or complete dependence on ventilation, interruption of ventilation could result in serious health consequences, possibly leading to death.
The problem was identified during internal laboratory testing. To date, the manufacturer is not aware of any market incidents or patient harm associated with this problem. |
| Instructions for Customers/Users |
Customers are to:
- Immediately check whether one of the affected firmware versions are installed on ventilators on hand.
- Update all affected ventilators to firmware version 1.15.0020 or higher.
- If you are unable to install the firmware update immediately, reset the device daily and before mobile use, use mains power where possible and keep an external battery connected where available. |
| Action Commencement Date |
14/10/2026 |
| Responsible Entity |
|
| Contact Information |
1300 861 139 - Lowenstein Medical Australia |