AMSCO
Received May 22, 2025 · Event occurred Apr 23, 2025
Report 3005899764-2025-00042 · MDR key 22069569
Device
Generic name
Amsco 400 Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 400 STEAM STERILIZERCatalog number
SR0201110311
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 WATER LEAK FROM THEIR AMSCO 400 STERILIZER. NO REPORT OF INJURY.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THAT THE CHECK VALVES TO THE UNIT WERE DAMAGED; HOWEVER, A CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE CHECK VALVES AND THE WATER INLET. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.