inforMED
MalfunctionFLE

AMSCO

Received Feb 12, 2025 · Event occurred Jan 13, 2025

Report 3005899764-2025-00014 · MDR key 21367870

Device

Generic name

Amsco 400 Steam Sterilizer

Catalog number

SR0101110011

Product problems

  • Mechanical Problem
  • Mechanical Problem

Patient

NA · Unknown

  • Burn(s)
  • Burn(s)

Narrative

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT AND FOUND THE S2 VALVE REQUIRED REPLACEMENT. THE VALVE CAUSED EXCESS STEAM TO REMAIN IN THE CHAMBER. WHEN THE EMPLOYEE OPENED THE DOOR AFTER RUNNING THE DART TEST, THE EXCESS STEAM RELEASED FROM THE UNIT CAUSING THE REPORTED EVENT. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE S2 VALVE. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A STEAM BURN TO THEIR HAND WHILE OPENING THE DOOR TO THEIR AMSCO 400 STEAM STERILIZER FOLLOWING A DAILY AIR REMOVAL TEST (DART). THE EMPLOYEE SOUGHT MEDICAL TREATMENT AND APPLIED A TOPICAL OINTMENT.