| Reason for the Action |
GE HealthCare has identified a problem affecting Carescape Central Station (CSCS) with software version V3.0.5, which can cause the system to enter a continuous reboot cycle.
If this occurs, a loss of central monitoring of connected patients could result. This problem occurs only when the number of central stations connected to the network is 118, 119 or 120.
There is a remote chance that the unexpected loss of the central station functionality, for multiple patients, could potentially lead to a delay in recognising and intervening for critical events e.g., life-threatening arrhythmia or severe desaturation. These delays could potentially result in permanent harm.
The reboot problem identified in CSCS V3.0.5 is only triggered when the number of CSCS devices on the network is exactly 118, 119, or 120 at the time the “Check centrals” function runs, which occurs every 12 hours. As the number of devices is typically fixed during installation and go-live, and changes to the network configuration are infrequent, the conditions required to trigger this problem are unlikely to occur during normal operation. Therefore, the risk of experiencing this reboot problem is considered remote.
There have been no injuries reported to GE HealthCare as a result of this problem.
Any versions prior to CSCS V3.0.5 are not affected. |