inforMED
MalfunctionFLE

AMSCO

Received May 29, 2025 · Event occurred Apr 30, 2025

Report 3005899764-2025-00045 · MDR key 22108581

Device

Generic name

Amsco 400 Sterilizer

Catalog 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.