BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO CLINICAL SYSTEM

    MDR report key: 2091512 · Received May 17, 2011

    Report

    Report Number
    2050012-2011-01805
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 16, 2011
    Report Date
    April 16, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND PREFORMED SERVICE ON THE INSTRUMENT. THE FSE REPLACED THE FAN ASSEMBLY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT SMOKE AND A LOUD SOUND WAS COMING FROM THE SYNCHRON LX20 PRO CLINICAL SYSTEM. THE CUSTOMER ALSO REPORTED THAT THE INSTRUMENT WAS GENERATING REAGENT CAROUSEL TEMPERATURE ERRORS AND PELTIER LOW CURRENT ALERTS. NO INJURY WAS REPORTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 PRO CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LX20 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1