The logbook of the affected device was available for the investigation.The log entries confirm that a warm start of the ventilation unit was carried out on (b)(6) 2019 at 11:52 pm.Ventilation was continued after the warm start.An unusually long duration of 9 months without switching off the device was identified as the cause of the warm start.The logbook entries show that the ventilator has been permanently switched on since (b)(6) 2018.Such a long time without switching off is highly unusual, as the device has to be switched off and the plug has to be pulled out according to the instructions for accessories assembly / disassembly and reprocessing.During a warm start of the ventilation unit, the emergency valve is opened against the environment to allow spontaneous breathing to the patient.After the successful warm start of the ventilation unit (duration approx.8 seconds), the alarm message "ventilation unit restarted" with accompanying acoustic alarm sequence is generated and ventilation is continued with the previously selected settings.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
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