AMSCO 400 STERILIZER
Received Jul 3, 2024 · Event occurred Jun 4, 2024
Report 3005899764-2024-00030 · MDR key 19672099
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Product problems
- Temperature Problem
- Temperature Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE STERILIZER AND FOUND THE HEATING ELEMENT WAS DAMAGED AND REQUIRED REPLACEMENT. THE TECHNICIAN REPLACED THE HEATING ELEMENT, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. A 3-YEAR COMPLAINT REVIEW INDICATES THIS TO BE AN ISOLATED EVENT. A FOLLOW UP MDR SHALL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THEIR AMSCO 400 STERILIZER MADE A "POPPING NOISE" AND HAD "SMOKE" COMING FROM THE BOTTOM OF THE UNIT. THE UNIT WAS REMOVED FROM SERVICE TO AWAIT ONSITE INSPECTION. NO REPORT OF INJURY.