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: issues with pressure.Probable root cause: pressure sensor malfunction/out of calibration, inflow cassette/ tubing pressure sensor membrane failure, mis-inserted cassette/ tubing, motor encoder malfunction/failure (inflow and/or outflow), roller wheel assembly (inflow and/or outflow) malfunction/failure, roller wheel failure due to peristaltic tubing debris build-up, main board (all) /imx failure (cf), software malfunction , use error , system design, unwanted movement of internal components/wiring, pressure sensor is operated above linear pressure reading range (>450 mmhg for cf) (design), pump operated at least-favorable environmental conditions for extended period of time run screen does not adequately indicate overpressure situation, miniwashmalfunction (cf), command not registered from hand control (all), footswitch (cf), sidne (fc, ap) or hermes (ap-hermes ready)excessive use of wash or turbo , slow reaction time to a quickly closed off shaver outflow at high flow rates, power failure of pump, pressure sensor stuck behind the sensor bracket, electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge, insufficient cybersecurity (cf).The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.
|