BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU643-02E CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2223810 · Received August 26, 2011

    Report

    Report Number
    2050012-2011-04752
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K961274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT AND FOUND THE AU640 ANALYZER TO BE OPERATIONAL AND PERFORMING TO SPECIFICATIONS. THE SOURCE OF THE BURNING SMELL WAS SOLELY FROM THE UNINTERRUPTIBLE POWER SUPPLY (UPS). THE FSE DISCONNECTED THE SYSTEM FROM THE UPS UNTIL A REPLACEMENT WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING A BURNING SMELL COMING FROM THE (B)(4) CLINICAL CHEMISTRY ANALYZER. NO INJURY WAS REPORTED IN THIS EVENT AS THE CUSTOMER MERELY NOTICED A SMOKE ODOR FROM THE SYSTEM AND POWERED IT OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU643-02E CLINICAL CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. AU643-02E N/A

    Patients

    Seq Age Sex Outcome Treatment
    1