| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01150-1 |
| Product Name/Description |
Drager V Series Ventilator with the Optional PS500 battery Installed
Affected models:
Infinity V500
Babylog VN500
Evita V300
All serial numbers affected
ARTG Numbers: 158739, 170141 and 92177 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
25/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
This recall is due to the unexpected shortening of the optional PS500 battery on an IACS Workstation Critical Care unit.
The batteries were discharged early, even though the device was indicating an adequate battery state of charge. The devices generate a "Battery Low" alarm, followed by "Battery Flat". In exceptional cases, the "Battery Flat" alarm might be displayed too late, or not at all. After complete discharge of the batteries, the device correctly alerts to failure of the power supply by the auxiliary alarm (piezo, power failure alarm) in all cases. It has been discovered that the current design of the charging algorithm for the new PS500 batteries is not able to appropriately prevent premature battery ageing in all application scenarios.
The unexpected loss of automatic ventilation functionality due to depleted battery requires immediate user intervention to prevent serious patient harm, including death. No patient injuries have been reported so far. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The sponsor Draeger is advising users not to use devices with the affected PS500 battery unit for patient transport until the firmware has been updated. |
| Contact Information |
03 9244 7248 - Draeger Medical Australia |