20" CENTURY STERILIZER
Received May 17, 2024 · Event occurred Apr 17, 2024
Report 3005899764-2024-00023 · MDR key 19340664
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Product problems
- Failure to Cycle
- Failure to Cycle
Patient
NA · Unknown
- Unspecified Respiratory Problem
- Unspecified Respiratory Problem
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN INSPECTED THE 20" CENTURY STERILIZER AND FOUND THAT A CONTACTOR WITHIN THE UNIT'S STEAM GENERATOR WAS IN THE CLOSED POSITION. THE STERIS TECHNICIAN REPLACED THE CONTACTOR, TESTED THE FUNCTION AND OPERATION OF THE 20" CENTURY STERILIZER AND CONFIRMED THE UNIT TO BE OPERATING TO SPECIFICATIONS. THE UNIT WAS RETURNED TO SERVICE AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE HAD "DIFFICULTY BREATHING" FROM AN ELECTRICAL SMELL THAT WAS EMITTING FROM THEIR 20" CENTURY STERILIZER. THE EMPLOYEE WENT TO THE FACILITY'S OCCUPATIONAL HEALTH DEPARTMENT. NO MEDICAL TREATMENT WAS ADMINISTERED.