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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 Draeger Medical Australia Pty Ltd
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