BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX® I 725 CLINICAL SYSTEM

    MDR report key: 1953418 · Received January 10, 2011

    Report

    Report Number
    2050012-2011-00072
    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
    K023049
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) FOUND WASH CONCENTRATE SOLUTION SPILLED IN THE HYDROPNEUMATIC DRAWER. FSE REPLACED THE WASH CONCENTRATE FLOAT SWITCH AND VALVES V12 AND V14.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO HYDROPNEUMATIC COMPARTMENT LEAK. NO INJURY WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX® I 725 CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LXI 725 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1