BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    733 HC

    MDR report key: 1457854 · Received August 20, 2009

    Report

    Report Number
    1457854
    Event Type
    Malfunction
    Date Received
    August 20, 2009
    Date of Event
    August 12, 2009
    Report Date
    August 20, 2009
    Manufacturer
    GETINGE USA INC.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    14 TRAYS BEING STERILIZED FOR SURGERY. 1 TRAY WAS WET WHEN OPENED AFTER 7 OTHER TRAYS FROM LOAD WERE USED ALREADY.MANUFACTURER RESPONSE (AS PER REPORTER) FOR STEAM STERILIZER, STERILIZERREPS CAME OUT TWICE TO EVALUATE. REPLACED JACKET TRAP AND REPLACED DRIP LEG TRAP THEN RELEASED UNIT FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 733 HC STERILIZER, STEAM FLE GETINGE USA INC. 733 HC 05E06109

    Patients

    Seq Age Sex Outcome Treatment
    1 *