inforMED
MalfunctionFLE

AMSCO 400 STERILIZER

Received Jun 5, 2024 · Event occurred Apr 26, 2024

Report 3005899764-2024-00024 · MDR key 19472647

Device

Generic name

Sterilizer

Product problems

  • Unintended Movement
  • Unintended Movement

Patient

NA · Unknown

  • Burn(s)
  • Burn(s)

Narrative

Additional Manufacturer Narrative

THE STERIS SERVICE TECHNICIAN ARRIVED ON SITE AND FOUND THAT THE DOOR DID NOT STAY OPEN. SURFACES INSIDE THE STERILIZER ARE HOT WHEN A CYCLE IS COMPLETED. THE OPERATOR MANUAL STATES THE FOLLOWING, "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." THE STERIS SERVICE TECHNICIAN ADJUSTED THE DOOR HINGE, TESTED THE UNIT, CONFIRMED OPERATING ACCORDING TO SPECIFICATIONS AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED

Description of Event or Problem

THE USER FACILITY REPORTED AFTER THE CYCLE RAN ON THEIR AMSCO 400 STEAM STERILIZER AN EMPLOYEE OBTAINED A BURN WHILE PREVENTING THE DOOR FROM CLOSING. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.