For the investigation the logfile was analysed.Other than initially reported no stop of ventilation occurred, no malfunction of the device was found.The logfile shows at the beginning of the case in question and again towards the end of the procedure leakages in the patient circuit, leading to a loss of pressure, volume and fresh gas.Possibly this was misinterpreted by the user.In case of decreased tidal volume and/or airway pressure, e.G.Caused by a significant circuit leak, the sufficient ventilation and oxygenation of the patient might be restricted.During system test and leakage test as well, internal and external leakages are detected and depending on size a conditional or non-functional state of the device is the consequence.Based on leakage, fresh gas flow settings and set alarm limits during ventilation several audible and visible alarms would be issued.All alarms, possible causes as well as remedies are described in the instructions for use.
|