| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01412-1 |
| Product Name/Description |
Infinity Acute Care Monitoring System (IACS) with software version VG5.0 and Microstream (Patient monitoring system)
ARTG Number: 168054 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
1/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
Draeger have become aware of two issues with the use of IACS software version VG5.0, as follows:
1. It is possible that expected audible alarms may not occur at both the IACS Cockpit and M540 although the appropriate audible and visual alarms will occur at the Infinity Central Station (ICS) and appropriate visual alarms will occur from the IACS System. This audible alarming anomaly could lead to missing expected audible alarms from IACS. The ICS alarms (visual and audible) as intended and lACS will still display visual alarms.
2. Microstream MCable CO2, which is supported by software version VG5.0, displays the incorrect Unit of Measure (UoM) in contradiction to the labelling. The monitor indicates that the UoM is mmHg, however, the actual value presented is in % Volume. The incorrect UoM could contribute to an error in the interpretation of the presented value. All distributed devices will have this anomaly.
There have been no injuries reported for the above issues. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Draeger will be contacting customers to arrange for downgrade of the IACS System to software version VG4. In the interim, customers can continue to use IACS software version VG5.0 but only if it is used in connection with an ICS or there is constant supervision of visual alarms at the bedside. The Microstream MCable is not to be used. This action has been closed-out on 28/06/2017. |
| Contact Information |
03 9244 7248 - Draeger Medical Australia |