BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX9 ALX

    MDR report key: 1860010 · Received October 7, 2010

    Report

    Report Number
    2050012-2010-00901
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 16, 2010
    Report Date
    October 5, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJC
    PMA / PMN Number
    K950958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE REPLACED WASTE CANISTER FLOAT SWITCH, WATER RESERVOIR FLOAT SWITCH, AND THE CX3 WASTE LINE TO EXIT CANISTER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING WASTE LEAK FROM THE HYDRO ON THE SYNCHRON CX9 ALX ANALYZER. NO INJURY WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX9 ALX CLINICAL CHEMISTRY ANALYZER JJC BECKMAN COULTER INC. CX9 ALX

    Patients

    Seq Age Sex Outcome Treatment
    1