The anesthesia system was investigated on-site and it was found that the inspiratory pressure transducer pcb was faulty.It was replaced and returned for investigation.Investigation of the returned inspiratory pressure transducer pcb found no visual deviations or damages on the pcb.Simulated use testing of the returned pcb reproduced the reported failure.The system check out failed in several tests due to the measured zero pressure offset for the inspiratory pressure transducer had drifted and exceeded the allowed limit (± 300 mv from factory default).Further test of the returned pcb concluded that the pressure sensor on the inspiratory pressure transducer pcb was broken.Evaluation of the received device logs confirmed the reported system check out failure.Our conclusion is that the reported failure was caused by a faulty pressure sensor on the inspiratory pressure transducer pcb.The root cause of the pressure sensor failure has not been determined.
|