3017 EO GAS STERILIZER
Received Mar 5, 2015 · Event occurred Feb 4, 2015
Report 3005899764-2015-00014 · MDR key 4571972
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Product problems
- Device Displays Incorrect Message
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE AND PUT THE STERILIZER IN SERVICE MODE TO PULL ANY REMAINING EO GAS IN THE CHAMBER. BEFORE THE TECHNICIAN'S ARRIVAL THE GAS WAS CONTAINED IN THE STERILIZER AND THE STERILIZER OPERATED PROPERLY TO PULL A VACUUM AFTER A CYCLE ALARM. THE TECHNICIAN OPENED THE STERILIZER DOOR AND FOUND THE GAS CANISTER NEEDLE STILL IN THE CANISTER. WHEN THE TECHNICIAN REMOVED THE CANISTER FROM THE STERILIZER THE EO MONITOR LOCATED BEHIND THE STERILIZER ALARMED DUE TO PROXIMITY OF THE CANISTER TO THE ALARM. DUE TO THE ALARM, THE ROOM WAS EVACUATED. THE TECHNICIAN STATED THAT A VALVE WAS NOT FUNCTIONING PROPERLY CAUSING THE NEEDLE TO PUNCTURE THE GAS CANISTER OUT OF SEQUENCE SUBSEQUENTLY CAUSING GAS TO RELEASE BEFORE THE STERILIZATION PHASE. THE TECHNICIAN REPAIRED THE UNIT, RAN A TEST CYCLE AND CONFIRMED IT TO BE OPERATIONAL. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT THEIR EO GAS STERILIZER ALARMED. NO INJURY WAS REPORTED.