BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 INSTRUMENT

    MDR report key: 2030087 · Received March 26, 2011

    Report

    Report Number
    1061932-2011-00191
    Event Type
    Malfunction
    Date Received
    March 26, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER THE INSTRUMENT IS OPERATIONAL. SERVICE REPLACED THE PRINTER. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE PRINTER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT A BURNING SMELL WAS COMING FROM THE PRINTER (OKIDATA B4600) OF THE COULTER LH 500 INSTRUMENT. THE CUSTOMER INDICATED THAT THE PAPER HAD A BURNT ORANGE APPEARANCE ACROSS THE TOP. THE OPERATOR POWERED OFF AND UNPLUGGED THE PRINTER. NO DEATH OR SERIOUS INJURY OCCURRED AS A RESULT OF THIS EVENT NOR WAS MEDICAL ATTENTION NEEDED. THERE WERE NO SHOCK, FLAMES, ARCING, OR VISIBLE SMOKE 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® LH 500 INSTRUMENT AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. LH 500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1