The ventilator failure described by the user could be reconstructed by means of the logfile analysis.No indications for a device malfunction were found.The autonomous safety shutdown of the ventilator was triggered by a significantly increased airway pressure peak.The reason for this was an existing lack of fresh gas during the case in combination with spontaneous breathing efforts of the patient.The device behaved as specified with an autonomous shutdown while changing mode to man/spont (safety mode) accompanied by an audible and visible "ventilator fail" alarm.In advance, the user was informed about the fresh gas deficiency and pressure situation (multiple alarms aw.Pressure high / pressure negative / fg low or leak).In order to avoid situations like this in the future, it was recommended to switch on the synchronization for spontaneously breathing patients (e.G.Pressure mode with activated trigger) or use synchronized ventilation mode (e.G.Pressure support).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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