| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00265-1 |
| Product Name/Description |
Infinity MCable Mainstream Sensor, Revision 16 only (used with Acute Care System (IACS) Monitoring Solution; and the Infinity M540 Stand-Alone Patient Monitor)
Part Number: 6871950
Serial Numbers: ASKJ-0016, ASKH-0285, ASKH-0287, ASKK-0180, ASKK-0323, ASKK-0381
ARTG Number: 140750
(Draeger Australia - Carbon dioxide sensor cable) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
Drager has determined that when the Infinity M540 Patient Monitor with software versions VG4.1 and below is used in combination with the Infinity MCable Mainstream C02 (M11.1) revision 16 sensor, the Infinity M540 Patient Monitor will reboot if the sensor enters a reduced accuracy mode. Should the Infinity M540 Patient Monitor reboot 3 times within a 10 minute period or less, the Infinity M540 Patient Monitor will go into a fail-state, resulting in a resetting to factory defaults, losing patient settings and stored patient data.
This issue only occurs with Infinity cable revision 16. There have been no injuries reported as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Drager is advising users to discontinue use the Infinity CO2 sensor, revision 16. Drager will be replacing all revision 16 cables with an earlier revision as an interim correction.
A software update will be implemented as a long term correction.
This action has been closed out on the 29/11/2018. |
| Contact Information |
03 9244 7248 - Drager Medical Australia |