BEUDAMED
    FDA Adverse Event Summary report: N

    20" CENTURY STERILIZER

    MDR report key: 3897179 · Received June 26, 2014

    Report

    Report Number
    3005899764-2014-00047
    Date Received
    June 26, 2014
    Date of Event
    May 31, 2014
    Report Date
    June 26, 2014
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY, INSPECTED THE STERILIZER AND FOUND THE CONNECTION AT THE UNIT'S JACKET EXHAUST REQUIRED REPAIR. THE TECHNICIAN MADE THE NECESSARY ADJUSTMENTS, PERFORMED A TEST CYCLE AND CONFIRMED THE UNIT WAS OPERATING TO SPECIFICATION. THE STERILIZER WAS INSTALLED IN AUGUST OF 2005 AND IS CURRENTLY UNDER STERIS SERVICE CONTRACT. THE LAST PREVENTIVE MAINTENANCE WAS COMPLETED ON MARCH 20, 2014 AT WHICH TIME THE UNIT WAS CONFIRMED TO BE OPERATING TO SPECIFICATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THEIR STERILIZER WAS LEAKING WATER. THE AMOUNT OF WATER WHICH LEAKED WAS APPROXIMATELY 1.5 GALLONS AND SPREAD THROUGHOUT THE FACILITY'S HALLWAY. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373435 20" CENTURY STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1