BEUDAMED
    FDA Adverse Event Summary report: N

    16" CENTURY STERILIZER

    MDR report key: 3881873 · Received June 18, 2014

    Report

    Report Number
    3005899764-2014-00042
    Date Received
    June 18, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 18, 2014
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE AND FOUND THAT THERE WAS AN EXPOSED WIRE WHICH WAS CONTACTING THE CHAMBER DOOR. THE WIRE HAD SHORTED CAUSING A SMALL SPARK AND MAIN FUSE ON THE UNIT TO BLOW. THE TECHNICIAN REPAIRED THE STERILIZER, RAN A TEST CYCLE AND CONFIRMED THE UNIT TO BE OPERATIONAL. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT SPARKS WERE OBSERVED TO BE COMING OUT THE FRONT OF THE STERILIZER. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357208 16" CENTURY STERILIZER CENTURY STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1