The ventilator failure described by the user could be reconstructed by means of the logfile analysis.No indications for a device malfunction were found.Also during on-site checking in follow-up to the event, no indications for a device malfunction leading to the reported symptom were found.Based on the logfile analysis, it could be reconstructed that the autonomous safety shutdown of the ventilator was triggered by a faulty motor position due to frequently changing positive and negative pressure peaks, as a result of the positioning of the patient and possibly the start of spontaneous breathing and/or coughing by the patient.At the time in question, pressure control ventilation was used; in general, it is 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 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.The number of similar cases, related to the same phenomenon, is within the expected range of the respective risk assessment and thus accepted.
|