A dräger fse was dispatched who examined the device on-site, could duplicate the reported observation and trace it back to the malfunction of a certain valve.The valve was replaced, the device passed all consecutive tests w/o deviations and it was returned to the facility in ready-to-use condition.The electronic device log file has been evaluated by the manufacturer.The findings derived from the logs are in line with the on-site evaluation results - the ventilator detected a repeatedly occurring expiratory flow during inspiration phases of the particular procedure.The observed reinstall vent alarm is the specified device response for such error condition.The error condition was not yet present in the daily self test done in the morning of the date of event but the next self test that was run on the following day detected the deviation exactly in the test step where the function of the particular valve is being tested that was later replaced.The valve was not available for evaluation and thus, it cannot be determined in detail what exactly led to the occurrence of a leakage while the concerned surgery was under way.The field failure rate of the valve is within accepted range.Dräger finally concludes that the device reacted as specified upon the malfunction of a single component and posted the corresponding alarms.The error condition affected automatic ventilation modes only; manual ventilation was still possible.
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