BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 1900771 · Received November 16, 2010

    Report

    Report Number
    2122870-2010-00732
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 19, 2010
    Report Date
    November 16, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TECHNICAL SERVICE (CTS) HAD CUSTOMER POWER DOWN INSTRUMENT AND WAIT FOR SERVICE TO ARRIVE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE INSPECTED THE INSTRUMENT AND DISCOVERED THE STEPPER MOTOR DRIVER BOARD AND POWER DISTRIBUTION RIBBON CABLE HAD BEEN SHORTED OUT. THE FSE REPLACED THE PARTS AND PRIMED THE SYSTEM. THE INSTRUMENT HAS ALL APPROPRIATE SAFETY RATINGS. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THAT DURING THE WEEKLY MAINTENANCE THEY NOTED SMOKE EMITTING FROM THE CARD CAGE OF THE ACCESS 2 PORTION OF THE DXC 600I INSTRUMENT. THERE WERE NO FLAMES OR FIRE, AND NO INJURY TO USER. THE FIRE DEPARTMENT WAS NOT DISPATCHED. THERE WAS NO CLINICAL IMPACT. NO FALSE RESULTS WERE GENERATED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1