| 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 |
|
| 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.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
03 9244 7248 - Draeger Medical Australia |