The ventilator failure described by the user could be reconstructed by means of the logfile analysis.No indications for a device malfunction were found.Root cause for the reported symptom was an overpressure at the patient end of the circuit leading to a pressure peak.Most likely, the unstable pressure situation was the result of a suction system being used while the patient was connected to the device.To prevent from damages, the system is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm.Manual ventilation and the monitoring functions remain available to the full extent.Dräger finally concludes that the device responded as specified upon the detected 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 root cause, is within the expected range of the respective risk assessment and thus accepted.
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