AMSCO EVOLUTION
Received Feb 13, 2025 · Event occurred Jan 16, 2025
Report 3005899764-2025-00016 · MDR key 21379078
Device
Generic name
Medium Evolution Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
HC-1500Catalog number
UE03
Product problems
- Leak/Splash
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED A STEAM LEAK FROM THEIR MEDIUM EVOLUTION STERILIZER. NO REPORT OF INJURY.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE MEDIUM EVOLUTION STERILIZER AND FOUND THAT THE STEM COMPONENT TO THE PRESSURE REGULATOR VALVE WAS DAMAGED, ALLOWING STEAM TO RELEASE FROM THE UNIT. THE MEDIUM EVOLUTION STERILIZER IS NOT UNDER A STERIS SERVICE CONTRACT FOR MAINTENANCE ACTIVITIES; THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. THE TECHNICIAN REBUILT THE PRESSURE REGULATOR VALVE, TESTED THE UNIT, CONFIRMED IT BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.