BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUSH SLUSH

    MDR report key: 679876 · Received January 20, 2006

    Report

    Report Number
    679876
    Event Type
    Malfunction
    Date Received
    January 20, 2006
    Date of Event
    December 19, 2005
    Report Date
    January 20, 2006
    Manufacturer
    O.R. SOLUTIONS, INC.
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING CARDIAC SURGERY, THE ROOM CLEAN-UP STAFF NOTED FLUID IN THE HUSH SLUSH MACHINE AFTER THE DRAPE WAS REMOVED. IT WAS NOTED THAT THE DRAPE HAD BEEN RESTING ON THE WARMER WHICH RESULTED IN A MELTING HOLE CAUSING A BREAK IN STERILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUSH SLUSH DRAPE, PLATE KKX O.R. SOLUTIONS, INC. ORS-2038D *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR