The reported ventilator failure and further issues about leakages and volume not reached could be comprehended by means of the log file analysis.The log file shows one entry that is logged when the airway pressure (paw) has gone very negative (less than -10mbar) during a ventilator operating mode.The device alarms for "pressure negative" if the measured paw is < ¿6.5 mbar.As a precaution, the piston pressure controller stops the ventilator temporarily and the device alarms accordingly with ¿ventilator fail¿.Monitoring and manual ventilation remains functional.Since no further entries were found in the log file, it can be assumed that the negative paw was most likely related to the surgical case, e.G.To the use of an external bronchial suction system.The investigation revealed as well that the device had a leakage during use.The fabius is equipped with integrated volume monitoring.If the delivered minute volume is less then set/expected, a visible and audible alarm will be generated depending on the alarm limits adjusted by the user (for example ¿minute volume low").By analyzing the log file it was found that the device did not pass the leak test that was performed prior to the case in question.The instructions for use of the device describes that the leakage test should be performed and all detected leakages should be remedied before using the device.A dräger service technician was dispatched to service the machine and no indications for a device malfunction were found; the device passed testing and was returned to use with no further problems reported.Dräger finally concludes, that the device responded as specified upon the symptom; no patient consequences have been reported.
|