BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU481-02E CLINICAL CHEMISTRY ANALYZER

    MDR report key: 1943277 · Received December 31, 2010

    Report

    Report Number
    2050012-2010-01792
    Event Type
    Malfunction
    Date Received
    December 31, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OPERATOR PERFORMED AN EMERGENCY STOP AND SHUTDOWN OF THE PC. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND DIAGNOSED THE PC AS HAVING A BAD POWER SUPPLY. FSE REPLACED THE COMPUTER BUT THE HARD DRIVE WOULD NOT INITIALIZE. THE FSE THEN SWAPPED THE ORIGINAL HARD DRIVE INTO NEW PC. THE FSE VERIFIED PC BOOT UP AND ANALYZER OPERATION. NO ISSUES HAVE OCCURRED SINCE VALIDATING THE SYSTEM WITH ISE, REAGENT, AND PHOTOCAL CALIBRATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT A STRONG PLASTIC AND ELECTRICAL BURNING SMELL WAS COMING FROM THE COMPUTER IN THE (B)(4) CLINICAL CHEMISTRY ANALYZER DURING INSTALL. NO INJURY WAS REPORTED. PATIENT RESULTS WERE NOT AFFECTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU481-02E CLINICAL CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. AU481-02E NA

    Patients

    Seq Age Sex Outcome Treatment
    1