AMSCO 400 STERILIZER
Received Sep 20, 2023 · Event occurred Aug 23, 2023
Report 3005899764-2023-00048 · MDR key 17782781
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 THAT STEAM WAS EMITTING FROM THEIR AMSCO 400 STERILIZER. NO REPORT OF INJURY.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN INSPECTED THE AMSCO 400 STERILIZER AND FOUND THAT ONE OF THE CONTACTORS ON THE GENERATOR'S HEATING ELEMENT WAS IN THE CLOSED POSITION. THE SAFETY VALVE RELEASED THE STEAM AS DESIGNED CAUSING THE REPORTED EVENT. THE TECHNICIAN REPLACED THE CONTACTOR AND HEATER ELEMENT, TESTED THE UNIT AND CONFIRMED IT TO BE OPERATING PROPERLY. THE AMSCO 400 STERILIZER WAS RETURNED TO SERVICE AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED.