Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00735-1
Product Name/Description Infinity Acute Care Monitoring System (IACS) used with Kontron C500 Cockpit

Kontron C500 Cockpits with revision index 06 or higher that contain 4GB RAM Modules

Multiple Cockpit Serial Numbers

ARTG Number: 168054
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 8/06/2017
Responsible Entity Draeger Medical Australia Pty Ltd
Reason/Issue Dräger has learned that Dräger Infinity Acute Care Systems that use the newer Kontron Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station due to high memory usage. The Infinity M540 will still issue both audible and visual alarms; the alarm function is not affected at the Infinity M540 and Infinity Central Station when the Cockpit is disconnected. To date, Dräger are not aware of any negative patient consequences arising from this issue.
Recall Action Recall for Product Correction
Recall Action Instructions Dräger will be contacting users to schedule a time to rework the identified devices by removing the affected Virtium RAM Modules and replacing them with the Swissbit version. In the interim, users are to remove the C500 Cockpit from service; the Infinity Acute Care System can be used without the C500 Cockpit as the Infinity M540 will function as the primary monitoring device once the Cockpit is disconnected.
Contact Information 03 9244 7248 - Draeger Medical Australia