| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00701-1 |
| Product Name/Description |
CARESCAPE B450, B650 and B850 Monitors (Bx50)
ARTG Number: 115304
(GE Healthcare Australia - Patient monitor, multiparameter) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
20/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
GE has been made aware when multiple CARESCAPE Monitor B450, B650, or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.
When a network overload occurs for a prolonged time, it is also possible that a CARESCAPE Monitor B850 is not rebooting but loses connection with the Patient Data Module (PDM) and a message “PDM Module Removed” is displayed.
Loss of overall monitoring for a prolonged time may lead to a delay in detection of permanent or irreversible impairment or life-threatening changes in the condition of the patient.
To date, GE has not received reports of injury as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
GE is advising users to take the actions outlined in the Customer Letter if a prolonged network overload occurs and the Bx50 monitor on the network does not resume normal functionality in approximately 90 seconds.
If a transient network overload occurs in which the Bx50 monitor on the network does restart within approximately 90 seconds (i.e., all functionality resumes and the monitor reconnects to the network automatically), complete only step #2 (not steps 1, 3, or 4) outlined in the Customer Letter to have the hospital IT department check network functionality.
For networks not maintained by GE, GE is advising users to verify the network in their facility meets the network configuration requirements.
This action has been closed out on 21/08/2019 |
| Contact Information |
1800 659 465 - GE National Call Centre |