AMSCO
Received Sep 25, 2024 · Event occurred Aug 26, 2024
Report 3005899764-2024-00049 · MDR key 20304721
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 400 STEAM STERILIZERCatalog number
SR0201210311
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 ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THAT THE WATER MANIFOLD BOLT WAS DAMAGED, CAUSING THE REPORTED EVENT. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE BOLT. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATIONS, AND RETURNED TO SERVICE. WHILE ONSITE, THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE PROPER REGULATION OF THE WATER PRESSURE FOR THE AMSCO 400 STERILIZER. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED A WATER LEAK ONTO THE FLOOR FROM THEIR AMSCO 400 STERILIZER. NO REPORT OF INJURY.