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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00989-1
Product Name/Description	Optional PS500 External Power Supply Unit Used in connection with Dräger V Series Ventilators Models: Infinity V500; Babylog VN500; Evita V300 ARTG Number: 158739
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	15/09/2014
Responsible Entity	Draeger Medical Australia Pty Ltd
Reason/Issue	Draeger has advised that in some cases in which the battery capacity of the optional PS500 Power Supply Unity of the Infinity ACS Workstation Critical Care (Evita Infinity V500) has reduced unexpectedly. The batteries in the PS500 were discharged prematurely, even though adequate battery charge status was displayed on the device. As a consequence of this, Draeger published a safety alert in February 2014, as well as a safety recall and the suspension of deliveries for devices using the PS500.
Recall Action	Recall for Product Correction
Recall Action Instructions	All PS500 Power Supply Units currently in use are in the process of being upgraded by the Dräger Service Engineers free of charge. A service-charging algorithm will be implemented, which prevents the problem of sulfation of the batteries, which was identified as a main reason for the reduction of the PS500 battery capacity.
Contact Information	03 9244 7248 - Drager Medical