BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT CLASSIC INSTRUMENT

    MDR report key: 497175 · Received November 18, 2003

    Report

    Report Number
    1039284-2003-00009
    Event Type
    Malfunction
    Date Received
    November 18, 2003
    Date of Event
    August 13, 2003
    Report Date
    November 7, 2003
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JTA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ONE OF THE CIRCUIT BOARDS ON THE BACT/ALERT CLASS INSTRUMENT CAUGHT FIRE. THE CUSTOMER PULLED THE POWER CARD AND THE FIRE WENT OUT. NO INJURIES WERE REPORTED. A FIELD SERVICE ENGINEER (FSE) WAS DIS-PATCHED TO THE SITE. THE FSE FOUND THE 3 CIRCUIT CARDS IN THE CARD CAGE/POWER ASSEMBLY WERE BURNT BADLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA