BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX® I 725 CLINICAL SYSTEM

    MDR report key: 1961914 · Received January 14, 2011

    Report

    Report Number
    2050012-2011-00170
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 18, 2010
    Report Date
    December 18, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2010 AND REPLACED THE IMPELLER FAN ON THE BACK PANEL BEHIND THE REAGENT COMPARTMENT. THE FSE TESTED AND VERIFIED PER ESTABLISHED PROCEDURES, WHICH MET PUBLISHED PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS SMOKE WAS APPEARING FROM THE BACK OF THE SYNCHRON LX I 725 CLINICAL SYSTEM. NO SPARKS OR FLAMES WERE NOTED. NO OPERATOR EXPOSURE WAS NOTED.

    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. LX®I 725 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1