Other than initially reported, no ventilation failure occured during operation.The logfile analyses showed that during operation the ventilation was restricted due to intraoperative circuit leaks, leading to a loss of pressure, volume and fresh gas.The device issued several alarms (e.G.Fresh gas low or leakage, apnea, minute volume low) during the case to call the attention of the user.Further it was found that during standby a sporadic outage of the bag pressure sensor occured.Appropriate alarms were given to the user.During system test and leak test as well, internal and external leakages are detected and depending on size a conditional (yellow) or non-functional (red) state is the consequence.Based on leakage, fresh gas flow settings and set alarm limits during ventilation several audible and visible alarms would be issued (e.G.Apnea, minute volume low, volume/airway pressure not achieved).All alarms, possible causes and remedies are described in the instructions for use.Draeger finally concludes that the device detected and alarmed a deviation during operation.During standby, when no active ventilation takes place, a faulty bag pressure sensor was detected and alarmed according to specification.Regarding the faulty bag pressure sensor the number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.The field failure rate is subject to permanent monitoring by the responsible product quality board and is rated as acceptable.H3 other text : on-going.
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