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.In case of such a reset, therapy will be interrupted for approximately 15 seconds.Afterwards, therapy will be continued with the last valid settings.Also in the particular case, the device behaved as specified after the reset and ventilation was continued without further problems for approx.One more hour until the case was completed by switching the device into standby mode.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 already 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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