AMSCO
Received Oct 24, 2023 · Event occurred Sep 25, 2023
Report 3005899764-2023-00054 · MDR key 17998988
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 600 STEAM STERILIZERCatalog number
EF1101222
Product problems
- Smoking
- Smoking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT THEIR AMSCO 600 STERILIZER WAS EMITTING SMOKE ALONG WITH A BURNING SMELL. NO REPORT OF INJURY.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE AMSCO 600 STERILIZER AND FOUND THAT THE GENERATOR'S THREE-PHASE CONTACTOR HAD SHORTED DUE TO IMPROPER CIRCUIT INSTALLATION. IT WAS DETERMINED THAT AN INCORRECT CIRCUIT BREAKER WAS INSTALLED BY THE USER FACILITY'S BIOMED ELECTRICIAN, CAUSING THE UNITS WIRES TO OVERHEAT. THE USER FACILITY HAD THE ELECTRICIAN REPLACE THE CIRCUIT BREAKER WITH THE CORRECT ONE AFTER DISCUSSION WITH STERIS. A STERIS SERVICE TECHNICIAN REPLACED THE STERILIZER'S DAMAGED COMPONENTS, TESTED THE UNIT, AND CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION. THE TECHNICIAN COUNSELED THE USER FACILITY'S BIOMED ABOUT THE IMPORTANCE OF USING THE CORRECT CIRCUIT BREAKER. THE STERILIZER WAS RETURNED TO SERVICE; NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Additional Manufacturer Narrative
UDI RELATED DATA QUALITY UPDATES ONLY - ALIGNMENT WITH GUDID.