| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-01309-1 |
| Product Name/Description |
All B20/B20i/B40/B40i, and B105/B125 patient monitors
ARTG Number: 92726
(GE MEDICAL SYSTEMS, AUSTRALIA LTD Patient monitor, multiparameter) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
26/09/2018 |
| Responsible Entity |
|
| Reason/Issue |
When multiple Bx0 or B1x5 patient monitors 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.
During the automatic restart cycle, the system will display a restart screen on the bedside monitor and the monitors will provide an extended audible tone during the restart. The central monitoring system in use will display a No Communication message. The Pro Clinical Information Center (CIC) and CARESCAPE Central Stations will display “NO COMM”, and iCentral “Connection to monitor lost” message.
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.
There have been no injuries reported as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
The sponsor recommends users who experience a network overload and have affected monitors that do not resume normal functionality within 90 seconds take the following actions:
1. Temporarily switch the monitor from central monitoring to local-only (bedside) monitoring as show in the customer letter.
2. Contact the IT department or other appropriate personnel in your facility responsible for the Patient Monitoring Network and provide them with the additional instructions on network configuration provided in the customer letter.
3. After the network issue has been resolved, switch the monitor back into central monitoring by re-connecting the Ethernet (LAN) cable to the appropriate port.
4. Verify correct monitoring state and alarm function.
GE Healthcare will provide revised network installation and user instructions documentation at no cost to users in a future mailing.
This action has been closed out on 21/01/2020 |
| Contact Information |
1800 659 465 - National Call Centre |