BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1865454 · Received October 12, 2010

    Report

    Report Number
    2050012-2010-00950
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 16, 2010
    Report Date
    October 11, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND FLUID CAME FROM CONDENSATION DRAIN FROM THE PUMP BOX. FSE REPOSITIONED THE DRAIN THE FLUID INTO PUMP BOX DRIP TRAY. FSE FOUND LEAK FROM THE CO2 ELECTRODE CHAMBER. THE ELECTRODE WAS MISSING THE QUAD RING. FSE REPLACED THE QUAD RING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING FLUID LEAKING UNDER THE HYDROPNEUMATIC AREA. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1