BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU5400 CHEMISTRY ANALYZER

    MDR report key: 2120752 · Received June 10, 2011

    Report

    Report Number
    2050012-2011-02253
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    BECKMAN COULTER MISHIMAK.K.
    Product Code
    JJE
    PMA / PMN Number
    K011720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED THE SYSTEM WITH A NEW PC AND STILL ENCOUNTERED BURNING SMELL AND RECEIVED ONLINE ERRORS. THE FSE INSPECTED THE SERIAL CABLE FOR CONNECTION TO THE (B)(4) PC. UPON INSPECTION IT WAS NOTED THAT THE CABLE WAS NOT PROPERLY PINNED. THE FSE ADDRESS THE MATTER BY BUILDING AN ISOLATION CONNECTOR FOR THE INTERFACE CABLE. THE FSE RAN THE SYSTEM WITH THE PC AGAIN WITHOUT ONLINE ERRORS AND BURNING SMELL.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT AFTER THE CUSTOMER INSTALLED A NEW PC ON THE (B)(4) UG CHEMISTRY ANALYZER, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR AN UNRELATED ISSUE AND NOTICED A BURNING SMELL COMING FROM THE PC. THE CUSTOMER ALSO INDICATED THAT THE INSTRUMENT WAS GENERATING ONLINE ERRORS. NO INJURY OR OPERATOR EXPOSURE OCCURRED FOR THIS EVENT, AS THE FSE MERELY NOTICED A FAINT SMOKE ODOR FROM THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU5400 CHEMISTRY ANALYZER AU5400 CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMAK.K. AU5400 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1