BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 1980944 · Received February 8, 2011

    Report

    Report Number
    1061932-2011-00067
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS NOT OPERATIONAL AND A FIELD SERVICE ENGINEER WAS DISPATCHED. WHEN THE FSE ARRIVED ON THE SITE, THERE WAS A SLIGHT "OVERHEATED MOTOR" SMELL. THE INSTRUMENT WAS TURNED OFF. THE FSE TRIED TO MANUALLY ROTATE THE MIX MOTOR; HOWEVER, WAS STUCK. THEREFORE THE DIFF MIX ASSEMBLY WAS REPLACED AND INSTRUMENT WAS TURNED ON. IT POWERED UP PROPERLY WITH ALL VOLTAGES AND NO ERRORS. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. UNIT IS CURRENTLY RUNNING. PER LABELING, BCI URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THE HMX SERIES PRODUCTS HAVE BEEN EVALUATED TO THE APPLICABLE (B)(4) STANDARDS. ROOT CAUSE OF THIS EVENT WAS ATTRIBUTED TO A DEFECTIVE DIFF MIX DRIVE ASSEMBLY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORTED THAT COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER LOCKED UP DISPLAYING (24 AND 6 VDC) ERRORS. IN ADDITION, WHEN THE CUSTOMER OPENED THE INSTRUMENT'S RIGHT SIDE DOOR A BURNING SMELL COULD BE DETECTED COMING FROM THE UPPER PART OF THE COMPARTMENT. THERE WAS NO REPORT OF FLAMES, ARCING OR SHOCK AND THERE WAS NO REPORT OF A FIRE EXTINGUISHER USED OR THE FIRE DEPARTMENT CALLED. NO DEATH OR SERIOUS INJURY OCCURRED AS A RESULT OF THIS EVENT AND MEDICAL ATTENTION WAS NOT SOUGHT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1