The logfile analysis carried out by the manufacturer revealed that a communication interrupt between the two processors onboard the therapy control unit have occurred during use.The device is designed to trigger a system reboot when such condition occurs.The reboot resulted in a short-term outage of therapy functions for approximately 14 seconds and was accompanied by a corresponding alarm before the therapy was resumed with the last valid settings.The particular procedure was continued and finished after approx.1 hour by switching the device into standby.Although the source of the deviation can be attributed to the particular pcb, the exact nature of the issue cannot be determined due to its sporadic nature.The number of similar cases, related to the same phenomenon, is within the expected range of the respective risk assessment and thus accepted.The respective board has been replaced as a precautionary measure; the workstation passed all consecutive tests and was returned to use without further problems reported.
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