The ventilator failure 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.Typical reason for this is an existing lack of fresh gas in combination with spontaneous breathing efforts of the patient.However, in the course of investigation, the user denied that the patient did breathe spontaneously or that suction was used.Nevertheless, no indications for a technical device failure were found ¿ the replaced motor unit was tested in a lab device and no deviations from specification were found.A test run for several days was successfully completed without any findings.Thus, the exact root cause for the found instable pressure situation cannot be determined finally.It can be concluded that the device in question behaved as specified upon the detected pressure situation with an autonomous shutdown while changing mode to man/spont (safety mode) accompanied by an audible and visible "ventilator fail" alarm.The number of similar cases, related to the same phenomenon, is within the expected range of the respective risk assessment and thus accepted.
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