BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER

    MDR report key: 2325757 · Received November 6, 2011

    Report

    Report Number
    1061932-2011-02126
    Event Type
    Malfunction
    Date Received
    November 6, 2011
    Date of Event
    October 6, 2011
    Report Date
    October 6, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO REPORT OBSERVING SMOKE AND A BURNING SMELL COMING FROM THE DIFF MIXING CHAMBER ON THE HMX INSTRUMENT. THE DIFF MIXING CHAMBER DID NOT STOP ROTATING. THE CUSTOMER POWERED OFF AND UNPLUGGED THE INSTRUMENT UNTIL SERVICE WAS PROVIDED. THE CUSTOMER DID NOT OBSERVE FIRE, ARCING, OR SPARKS. NO SHOCK, INJURY, OR DEATH WAS REPORTED AND MEDICAL ATTENTION WAS NOT SOUGHT. PATIENT SAMPLE RESULTS AND/OR TREATMENT WAS AFFECTED BY THIS EVENT ON (B)(4)-2011 A BEC FIELD SERVICE ENGINEERING (FSE) REPLACED THE MIXING CHAMBER TO REPAIR THE INSTRUMENT. THE ROOT CAUSE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER HMX HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER INC. HMX AL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1