This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: possibly faulty or misuse of an insufflator.Probable root cause: pressure sensor malfunction / out of calibration, software malfunction, use error, system design, unwanted movement of internal components / wiring, pressure button does not disengage, electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge, venting valve system or overpressure alarm failure, safety valve or regulator malfunction, hpu or lpu assembly malfunction, ppv failure, manufacturing/ service error.The reported failure mode will be monitored for future reoccurrence.
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