AMSCO 400 STERILIZER
Received Jun 5, 2024 · Event occurred Apr 26, 2024
Report 3005899764-2024-00024 · MDR key 19472647
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.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.