BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT CLASSIC INSTRUMENT

    MDR report key: 496154 · Received September 10, 2003

    Report

    Report Number
    1039284-2003-00006
    Event Type
    Malfunction
    Date Received
    September 10, 2003
    Date of Event
    April 30, 2003
    Report Date
    September 9, 2003
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JTA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED AND REPORTED THAT THE BACT/ALERT CLASSIC INSTRUMENT WAS EMITTING A BURNING SMELL. A BMX FIELD ENGINEER WAS SENT TO THE SITE AND DISCOVERED THAT THE CARD CAGE IN THE CABINET AND THE POWER SUPPLY HAD CAUGHT FIRE. ONE FIRE WAS SELF-EXTINGUISHED. NO ONE IN THE LABORATORY WAS INJURED AND THERE WAS NO DAMAGE TO THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ALERT CLASSIC INSTRUMENT MICROBIAL GROWTH MONITOR JTA BIOMERIEUX, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA