AMSCO
Received Feb 7, 2025 · Event occurred Jan 9, 2025
Report 3005899764-2025-00011 · MDR key 21336211
Device
Generic name
Amsco 600 Steam Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 600 STEAM STERILIZERCatalog number
EF1201242
Product problems
- Leak/Splash
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ON SITE TO INSPECT THE AMSCO 600 STERILIZER AND FOUND IT NOT OPERATIONAL, UPON FURTHER INSPECTION THE TECHNICIAN FOUND THAT THE LEAK WAS COMING FROM THE SIGHT GLASS DUE TO A DAMAGED GASKET. TO RESOLVE THE ISSUE, THE TECHNICIAN REPAIRED THE SIGHT GLASS WITH A REPAIR KIT, TESTED THE UNIT, FOUND IT TO BE OPERATING TO SPECIFICATION, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT THEIR AMSCO 600 STERILIZER WAS LEAKING WATER ONTO THE FLOOR. NO REPORT OF INJURY.