Alleged failure: excessive co2.Probable root cause: pressure sensor malfunction / out of calibration, software malfunction, use error, system design, unwanted movement of internal components / wiring, insufflator operated at least-favorable environmental conditions for an extended, period of time.Pressure button does not disengage.The device manufacture date is not known.The product was not returned for investigation; therefore, the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.
|