BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX5 DELTA

    MDR report key: 1954575 · Received January 10, 2011

    Report

    Report Number
    2050012-2011-00053
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K942676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND DID A THROUGH CHECK OF THE SYSTEM FOR LEAKS ON THE POWER SUPPLIES OR BOARDS. THE FSE REMOVED ALL INSTRUMENT COVERS AND CHECKED THE BOARDS FOR ANY BURNT SPOTS, BUT COULD NOT FIND ANY. THE FSE APPLIED POWER TO THE SYSTEM AND CALIBRATED ISE TESTS AND RAN A TEST SAMPLE ON THE CX4 SIDE. THE FSE CHECKED ALL MOTORS, PERFORMED A CUVETTE WASH LOOKING FOR ANY LEAKING ON ANY BOARDS THAT MAY HAVE CAUSED THE BURNING SMELL BUT DID NOT FIND ANY LEAKS. THE FSE CHECKED ALL THE BOARDS ON THE INSTRUMENT, BUT DID NOT FIND ANY BURNT SPOTS ON ANY OF THE BOARD. THE FSE DID NOT FIND ANY MALFUNCTIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THAT SYNCHRON CX5 DELTA INSTRUMENT PRODUCED A BURNING SMELL BUT NO SMOKE. CUSTOMER SHUT DOWN AND UNPLUGGED SYSTEM. THE LABORATORY WAS EVACUATED AND THE FIRE DEPARTMENT WAS CALLED. CUSTOMER WAS NOT RUNNING SAMPLES AT THE TIME. NOBODY WAS AFFECTED BY BURNING SMELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX5 DELTA CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. CX5 DELTA

    Patients

    Seq Age Sex Outcome Treatment
    1