BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLUSH

    MDR report key: 948922 · Received November 6, 2007

    Report

    Report Number
    948922
    Event Type
    Malfunction
    Date Received
    November 6, 2007
    Date of Event
    October 24, 2007
    Report Date
    November 6, 2007
    Manufacturer
    ADVANCE MEDICAL DESIGNS INC.
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    WHEN REMOVED THE SLUSH DRAPE FROM THE SOLUTION WARMER, NOTED 400CC OF SOLUTION UNDER SLUSH DRAPE. RN VISUALLY INSPECTED THE SLUSH DRAPES BUT UNABLE TO LOCATE ANY HOLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLUSH DRAPE, COOLING KKX ADVANCE MEDICAL DESIGNS INC. * 60406C6061

    Patients

    Seq Age Sex Outcome Treatment
    1 *