The Therapeutic Goods Administration (TGA) of Australia has issued a medical device safety alert concerning All B20/B20i/B40/B40i, and B105/B125 patient monitors, manufactured by GE Medical Systems Information Technologies
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.
According to the manufacturer, 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.
The manufacturer recommends users who experience a network overload and have affected monitors that do not resume normal functionality within 90 seconds take the following actions:
For details, please refer to the TGA website:
https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01309-1
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 28 September 2018