BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU403-02E CLINICAL CHEMISTRY ANALYZER

    MDR report key: 1994175 · Received February 16, 2011

    Report

    Report Number
    2050012-2011-00473
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K981743
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED FOR THIS EVENT. THE AU400 WAS NOT THE SOURCE OF BURNING SMELL. A CIRCUIT CARD ON THE UPS CONNECTED TO AU400 HAD BURNT. THE FIELD SERVICE ENGINEER (FSE) PLUGGED THE AU400 TO THE WALL POWER AND VERIFIED THE INSTRUMENT OPERATION. THERE WAS NO DAMAGE TO THE AU400 AND THE OPERATION WAS NOT AFFECTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO SMOKE ODOR FROM AU400 CHEMISTRY ANALYZER. THE CUSTOMER STOPPED THE ANALYZER AND CALLED THE FIRE DEPARTMENT. THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU403-02E CLINICAL CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1