AMSCO
Received May 29, 2025 · Event occurred Apr 30, 2025
Report 3005899764-2025-00045 · MDR key 22108581
Device
Generic name
Amsco 400 Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 400 STEAM STERILIZERCatalog number
SR0101110311
Product problems
- Leak/Splash
- Leak/Splash
Patient
NA · Unknown
- Fall
- Fall
Narrative
Additional Manufacturer Narrative
A STERIS TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT AND FOUND THE FLARE FITTING ON THE GENERATOR'S DRAIN SYSTEM WAS LOOSE WHICH ALLOWED WATER TO LEAK CAUSING THE REPORTED EVENT. TO RESOLVE THE ISSUE, THE TECHNICIAN TIGHTENED THE FLARE FITTING, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE SLIPPED AND FELL ON WATER LEAKING FROM THEIR AMSCO 400 STERILIZER. THE EMPLOYEE SOUGHT MEDICAL TREATMENT; IT IS UNKNOWN IF MEDICAL TREATMENT WAS ADMINISTERED.