AMSCO
Received Oct 4, 2024 · Event occurred Sep 6, 2024
Report 3005899764-2024-00052 · MDR key 20368943
Device
Generic name
Amsco 400 Steam Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 400 STEAM STERILIZERCatalog number
SR0101110311
Product problems
- Leak/Splash
- Leak/Splash
Patient
NA · Unknown
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT FOLLOWING AN ABORTED CYCLE, AN EMPLOYEE SUFFERED A BURN TO THEIR FACE AND A BLISTER ON THEIR LIP WHEN THEIR FACE CONTACTED STEAM AFTER OPENING THEIR AMSCO 400 STERILIZER DOOR. THE EMPLOYEE SOUGHT MEDICAL TREATMENT AND WAS GIVEN ICE.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT AND FOUND A HOLE IN THE VALVE DIAPHRAGM WHICH CAUSED POOR LEVEL VACUUMS AND LED TO THE UNIT ABORTING. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE VALVE. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. A 3-YEAR COMPLAINT REVIEW INDICATES THIS IS AN ISOLATED EVENT. THE AMSCO 400 SERIES SMALL STEAM STERILIZER OPERATOR MANUAL STATES (PG. 6-3), "WARNING - BURN HAZARD: STEAM MAY BE RELEASED FROM THE CHAMBER WHEN DOOR IS OPENED. STEP BACK FROM THE STERILIZER EACH TIME THE DOOR IS OPENED TO MINIMIZE CONTACT WITH STEAM VAPOR." THE TECHNICIAN COUNSELED THE USER FACILITY ABOUT THE IMPORTANCE OF STEPPING BACK FROM THE STERILIZER EACH TIME THE DOOR IS OPENED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.