BEUDAMED
    FDA Adverse Event Summary report: N

    20" CENTURY VACUUM STEAM STERILIZER

    MDR report key: 4122270 · Received September 26, 2014

    Report

    Report Number
    3005899764-2014-00093
    Date Received
    September 26, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 26, 2014
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS FIELD SERVICE TECHNICIAN ARRIVED ONSITE AND INSPECTED THE UNIT. THE TECHNICIAN IDENTIFIED THAT THE CAUSE OF THE LEAK WAS DUE TO A WORN DRAIN FUNNEL. THE TECHNICIAN REPLACED THE DRAIN FUNNEL, TESTED THE STERILIZER, AND CONFIRMED THE UNIT WAS OPERATING ACCORDING TO SPECIFICATION. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A LEAK FROM THEIR CENTURY STERILIZER. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600866 20" CENTURY VACUUM STEAM STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1