This complaint investigation was closed based 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: loss of insufflation.Probable root cause: pressure sensor malfunction / out of calibration.Software malfunction.Use error.System design.Unwanted movement of internal components / wiring.Power button inadvertently turned off.Tube set/gas supply inadvertently detached/loose.Loss of power.Pressure button does not disengage.Electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge.Hpu or lpu assembly malfunction.Leaks from internal connections or seals.Ppv failure.Manufacturing/ service error.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.
|