AMSCO 400 STERILIZER
Received Jul 10, 2025 · Event occurred Jun 11, 2025
Report 3005899764-2025-00060 · MDR key 22474182
Device
Generic name
Amsco 400 Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Product problems
- Leak/Splash
- Leak/Splash
Patient
NA · Unknown
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT AND LEARNED THAT THE UNIT HAD ALARMED "TRANSDUCER FAILURE". TO CLEAR THE ALARM, THE EMPLOYEE TURNED THE UNIT OFF AND THEN BACK ON. ONCE THE UNIT WAS BACK ON THE UNIT ALARMED "ATMOSPHERIC PRESSURE IN CHAMBER". THE EMPLOYEE THEN OPENED THE STERILIZER'S DOOR RESULTING IN THE REPORTED EVENT. BOTH ALARMS CAN INDICATE EXCESS STEAM PRESSURE IN THE CHAMBER OF THE STERILIZER. THE AMSCO 400 STERILIZER OPERATOR MANUAL STATES (PG. 2), 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. WHILE ONSITE, THE TECHNICIAN REPLACED THE NECESSARY COMPONENTS, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A STEAM BURN TO THEIR FINGERS WHILE OPENING THE DOOR TO THEIR AMSCO 400 STERILIZER. THE EMPLOYEE RINSED THEIR FINGERS WITH WATER, APPLIED OINTMENT AND RETURNED TO WORK.