BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2912474 · Received January 12, 2013

    Report

    Report Number
    1061932-2012-02948
    Event Type
    Malfunction
    Date Received
    January 12, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BECKMAN COULTER, INC. FIELD SERVICE ENGINEER (FSE) WAS AT THE CUSTOMER'S SITE TO REPAIR THE COULTER LH 750 HEMATOLOGY ANALYZER FOR "PROBE WIPE NOT UP" ERRORS. THE FSE NOTICED THE PROBE WIPE ACTUATOR WAS RECEIVING 5 VOLTS AND NOT THE 24 VOLTS NECESSARY TO DRIVE THE ACTUATOR. THE FSE REPLACED THE OPTICS SUPPLY AND THE 24 VOLTS WERE PRESENT BUT THE PROBE WIPE WAS STILL NOT WORKING. THE FSE THEN NOTICED A BURNING SMELL AND SAW A LIGHT STREAM OF SMOKE FROM THE DILUTER 2 CARD. THE FSE REPLACED THE DILUTER 2 CARD AND THE PROBE WIPE ASSEMBLY AND THE INSTRUMENT RAN WITHOUT ANY ERRORS OR HAZARDS. THE FSE DETERMINED THE CAUSE OF THE BURNING SMELL WAS A SHORT CIRCUIT ON THE DILUTER 2 CARD. THE CAUSE FOR THE "PROBE WIPE NOT UP" ERRORS WAS THE PROBE WIPE. THE FSE WAS WEARING A LAB COAT, GLOVES, AND EYE PROTECTION. THE FSE DID NOT OBSERVE ANY SPARKS, ARCS, OR FLAMES, BUT DID NOTICE A BURN SMELL. PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19255 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1