| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00659-1 |
| Product Name/Description |
CARESCAPE Monitor B850, B650 or B450 Monitors with V2 software versions (Multiparameter patient monitors)
ARTG Number: 115304 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently become aware of a potential safety issue due to partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2, the PDM may not start communicating to the monitor and loss of the PDM parameters could occur. This issue happens after the following sequence of events:
1. The PDM is connected to a Transport Pro or Solar monitor.
2. At least one arrhythmia or ST-change snapshot is saved in the PDM.
3. The PDM is then connected to the CARESCAPE Bx50 monitor.
4. More than 740 arrhythmia or ST-change snapshots are then saved in the PDM.
5. The PDM is then disconnected and connected back to the CARESCAPE Bx50 monitor.
|
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are advised to follow these instructions provided in the customer letter to configure the CARESCAPE Bx50 monitor to store snapshots locally only and to prevent the PDM from starting to store the snapshots. A PDM that has exceeded the snapshot quantity and becomes unresponsive to CARESCAPE Bx50 monitors can be reset by connecting it to a Solar or Transport Pro monitor and doing a discharge. This process may need to be performed multiple times to clear all of the snapshot data. GE Healthcare will implement a software solution a permanent fix. This action has been closed-out on 02/02/2016. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |