Other than initially described it was found during the course of the logfile analysis that the device failed during operation.The logfile analysis showed that the case in question was started and ventilation was unremarkable.After some time of ventilation a control signal failure was detected and a turbo vent 2 failure alarm was given.The user continued ventilation using man/spont before putting the device into standby.The turbovent 2 (blower) generates the preset airway pressure.In the case of a turbovent2 failure automatic ventilation is no longer possible and the corresponding alarm is given.Fresh gas dosage and manual ventilation remains available.The exact root cause couldn¿t be determined as the replaced hardware was not available for an in-depth analysis.However the problem was most likely caused by a faulty pba component.Since replacement oft he pba has fixed the problem it was concluded that the root cause was located onboard that pba.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
|