BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2171212 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00774
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    March 26, 2008
    Report Date
    March 26, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER IS LISTED BY (B)(6) TO THE FOLLOWING STANDARDS: (B)(4). NOTE: (B)(6). ON (B)(4) 2008, THE FIELD SERVICE ENGINEER EVALUATED THE ANALYZER AND IDENTIFIED THAT THE DIFFERENTIAL CHAMBER MIX MOTOR WAS SMOKING SLIGHTLY AND WOULD NOT MIX. THE FSE REPLACED THE MIX MOTOR AND VERIFIED REPAIR PER SPECIFICATIONS. ROOT CAUSE WAS ATTRIBUTED TO THE HARDWARE REPLACED BY THE FSE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BURNING SMELL WHILE USING THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE CUSTOMER WAS EXPOSED TO A SMALL AMOUNT OF SMOKE. THE CUSTOMER DID NOT SEEK MEDICAL TREATMENT. CUSTOMER DISCONNECTED POWER FROM THE ANALYZER AND SERVICE WAS REQUESTED. THERE WERE NO FLAMES, ARCS OR SHOCK. THE FIRE DEPARTMENT WAS NOT CALLED. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA