BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® 20 PRO SYSTEM

    MDR report key: 2141896 · Received June 28, 2011

    Report

    Report Number
    2050012-2011-02653
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 28, 2011
    Report Date
    May 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) FOUND THE TUBING THAT CONNECTS THE DI WATER VALVE TO THE WASH CANISTER HAD SPLIT. FSE REPLACED THE TUBING AND RAN THE INSTRUMENT; NO ERRORS OBSERVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) CUSTOMER TECHNICAL SUPPORT (CTS) TO REPORT A LEAK UNDER THE HYDRO PNEUMATIC ASSEMBLY AREA. PER CUSTOMER, UNABLE TO FIND THE SOURCE OF THE LEAK. NO INJURY OR EXPOSURES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX® 20 PRO SYSTEM DISCRETE CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1