BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH750 HEMATOLOGY ANALYZER

    MDR report key: 2009301 · Received March 7, 2011

    Report

    Report Number
    1061932-2011-00114
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    February 5, 2011
    Report Date
    February 5, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND REPLACED THE POWER SUPPLY AND SOME OTHER HARDWARE. THE INSTRUMENT WAS POWERED UP AND IS OPERATIONAL.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING A LOUD POPPING NOISE WAS HEARD FROM THE BACK OF THE COULTER LH750 HEMATOLOGY ANALYZER FOLLOWED BY AN ELECTRICAL BURN SMELL AND A SMALL AMOUNT OF VISIBLE SMOKE FROM THE BACK OF THE INSTRUMENT AND FROM THE POWER SUPPLY. THE OPERATOR POWERED OFF AND UNPLUGGED THE INSTRUMENT. THERE WAS NO SHOCK, FLAMES OR ARCING OBSERVED. THE FIRE DEPARTMENT WAS NOT CALLED AND NO ONE SOUGHT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH750 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1