| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01162-1 |
| Product Name/Description |
Infinity Acute Care System (IACS) Monitoring Solution (Patient monitoring system)
Software versions VG2.03 and higher are affected
Multiple serial numbers affected
ARTG Number: 168054 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
12/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has found that if a low SpO2 yellow medium grade alarm is displayed and paused by the user, the IACS did not generate the SpO2 (red) high grade life threatening SpO2 low alarm on the cockpit and the central station; only the patient monitor (M540) showed the red signal. The correct SpO2 value is indicated on all devices. This IACS behaviour happens only in the neonatal mode. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Draeger Medical is recommending users not to pause the medium grade SpO2 low alarm without adequate patient surveillance. A software update is being developed as a permanent fix and should be available in March 2014. |
| Contact Information |
1800 800 327 - Draeger Medical Australia |