| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01136-1 |
| Product Name/Description |
PDM module with Frame F5-01 used with CARESCAPE Monitor B850
ARTG Number: 115304 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
The PDM patient parameter acquisition module can sometimes spontaneously lose the communication with the host patient monitor when attached to the F5-01 Frame due to an issue with the PDM Ethernet communication hardware. The communication loss may occur when the PDM is first attached to the host monitor, or it may lose communication spontaneously during use with no user action. Communication is not automatically re-established. Loss of communication with the host monitor results in a loss of monitoring for the parameters provided by the PDM module, however an audible and visual alarm will be displayed. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare are providing work around instructions for users to follow. GE will be replacing the affected frames as a permanent correction. This action has been closed-out on 10/02/2016. |
| Contact Information |
1800 659 465 - National Call Centre |