BEUDAMED
    FDA Adverse Event Summary report: N

    16" CENTURY STEAM STERILIZER

    MDR report key: 3023836 · Received March 27, 2013

    Report

    Report Number
    3005899764-2013-00028
    Date Received
    March 27, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 27, 2013
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE STERILIZER, AND FOUND THE STEAM GENERATOR HEATER AND RELAY CONTACTOR TO BE DAMAGED. THE TECHNICIAN REPLACED THE COMPONENTS, TESTED THE STERILIZER, FOUND IT OPERATIONAL AND RETURNED IT TO SERVICE. THE UNIT WAS MANUFACTURED ON 10/7/2008, AND IS UNDER STERIS SERVICE CONTRACT. STERIS MONTERREY QUALITY REVIEWED THE DHR FOR THIS UNIT, AND FOUND IT TO BE MANUFACTURED ACCORDING TO SPECIFICATIONS. STERIS ENGINEERING CONFIRMED THAT THIS INCIDENT IS AN ISOLATED EVENT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE STEAM STERILIZER MADE A LOUD POPPING NOISE AND TRIPPED THE POWER. THE UNIT WAS SMOKING AND SHUT DOWN. THE FIRE DEPARTMENT WAS DISPATCHED TO THE FACILITY. NO EVACUATION OF THE FACILITY OCCURRED. NO INJURIES WERE REPORTED. NO PROCEDURAL DELAYS OR CANCELLATIONS WERE REPORTED. NO PROPERTY DAMAGE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125088 16" CENTURY STEAM STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1