AMSCO 400 STERILIZER
Received Jan 3, 2024 · Event occurred Dec 4, 2023
Report 3005899764-2024-00001 · MDR key 18437925
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Product problems
- Leak/Splash
- Leak/Splash
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED WATER LEAKED FROM THEIR AMSCO 400 STERILIZER ONTO THE FLOOR. NO REPORT OF INJURY.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE STERILIZER AND FOUND THAT AT THE TIME OF THE EVENT THE STEAM GENERATOR OVER FILLED CAUSING WATER TO BE RELEASED FROM THE RELIEF VALVE. THE TECHNICIAN FURTHER INSPECTED THE UNIT AND FOUND IT TO BE OPERATING PROPERLY. THE TECHNICIAN WAS UNABLE TO DETERMINE WHAT CAUSED THE STEAM GENERATOR TO OVER FILL. THE TECHNICIAN PROACTIVELY CLEANED THE WATER LEVEL PROBE AND ADJUSTED THE STEAM JACKET VALVE, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATIONS, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.