AMSCO
Received Mar 1, 2025 · Event occurred Jan 30, 2025
Report 3005899764-2025-00020 · MDR key 21499640
Device
Generic name
Amsco 400 Steam Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 400 STEAM STERILIZERCatalog 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.