inforMED
MalfunctionFLE

AMSCO

Received Mar 1, 2025 · Event occurred Jan 30, 2025

Report 3005899764-2025-00020 · MDR key 21499640

Device

Generic name

Amsco 400 Steam Sterilizer

Catalog number

SR2221211011

Product problems

  • Failure to Align
  • Failure to Align

Patient

NA · Unknown

  • Burn(s)
  • Burn(s)

Narrative

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE AMSCO 400 STERILIZER AND FOUND THAT THE DOOR HINGES ON THE UNIT WERE OUT OF ALIGNMENT WHICH CAUSED THE DOOR TO DRIFT SLIGHTLY WHEN OPEN. TO RESOLVE THE ISSUE, THE TECHNICIAN ADJUSTED THE DOOR HINGES, TESTED THE UNIT, FOUND IT TO BE OPERATING ACCORDING TO SPECIFICATIONS, AND RETURNED IT TO SERVICE. THE AMSCO 400 STERILIZER OPERATOR MANUAL STATES THE FOLLOWING, "WARNING - BURN HAZARD: STERILIZER, RACK/SHELVES, AND LOADING CAR WILL BE HOT AFTER CYCLE IS RUN. ALWAYS WEAR PROTECTIVE GLOVES AND APRON WHEN REMOVING A PROCESSED LOAD. PROTECTIVE GLOVES AND APRON MUST BE WORN WHEN RELOADING STERILIZER FOLLOWING THE PREVIOUS OPERATION." NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT WHILE AN EMPLOYEE WAS LOADING THEIR AMSCO 400 STERILIZER THEIR ELBOW CONTACTED THE DOOR AND OBTAINED A BURN. THE EMPLOYEE DID NOT SEEK MEDICAL TREATMENT AND CONTINUED WORKING.