| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00572-1 |
| Product Name/Description |
Xhibit Central Station (patient monitoring system)
Model Number: 96102
Serial Numbers: SLA1114F00831, SLA0114F00450
ARTG Number: 237776 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Spacelabs, has received one report of values for patient height and weight being switched when input at the Xhibit Central Station, causing a bedside monitor Body Surface Area (BSA) calculation to be in error. No one has been injured due to this error.
In order for the error to occur, the height and weight values must have been entered at the Xhibit Central Station, the Cardiac Output cable must be attached for use, and the Cardiac Output function on the bedside monitor must be initiated. The BSA value is determined by the monitor from height and weight of the patient and is used in subsequent hemodynamic calculations such as Cardiac Index.
The bedside monitor also contains a “drug calculator” for computation of drug dose conversions by weight or other units of measure. In situations where the failure mode has occurred, this initial value will not be accurate due to the height and weight transposition. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ecomed is providing users with work around instructions to follow as an interim measure. Affected customers will be provided with a software upgrade as a permanent correction. This action has been closed-out on 27/01/2017. |
| Contact Information |
1800 675 432 - Ecomed Regulatory Department |