BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX 20 PRO CLINICAL SYSTEMS

    MDR report key: 2001987 · Received February 27, 2011

    Report

    Report Number
    2050012-2011-00583
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) FOUND ONE OF THE WASH CONCENTRATE SUPPLY VALVES WAS LEAKING FROM THE BOTTOM. FSE REPLACED THE TUBING FOR ALL THREE-WAY PRESSURE/VACUUM VALVES AND ALL THE TUBING FOR THE TWO-WAY FLUIDICS VALVES REPLACED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A LEAK UNDERNEATH THE SYNCHRON LX 20 PRO CLINICAL SYSTEM. NO INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1