BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMERIEUX BACT/ALERT MICROBIAL DETECTION SYSTEM

    MDR report key: 2371957 · Received December 8, 2011

    Report

    Report Number
    MW5023406
    Event Type
    Malfunction
    Date Received
    December 8, 2011
    Date of Event
    November 5, 2011
    Report Date
    December 8, 2011
    Manufacturer
    BIOMERIEUX
    Product Code
    JTA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE BIOMERIEUX BACT/ALERT MICROBIAL DETECTION SYS PRESENTED WITH A MESSAGE "INSTRUMENT 2 IS NOT RESPONDING." THE CONTROLLER SCREEN ON INSTRUMENT 2 WAS COMPLETELY BLACK AND NO POWER WAS GOING TO THE CONTROLLER. THE INCUBATORS ASSOCIATED WITH THE CONTROLLER CONTAINED CULTURE BOTTLES FROM 172 PHORESIS COLLECTIONS. LOSS OF POWER TO THE CONTROLLER FOR THE CULTURE BOTTLES. CONTRIBUTING FACTORS MAY HAVE BEEN THAT THE POWER TO THE BACT CONTROLLER WAS DISRUPTED CAUSING THE INTERNAL UPS (BATTERY MODE) TO SUPPLY POWER. THE INTERNAL CIRCUITRY FAILED TO ALLOW THE UPS TO SWITCH BACK TO AC MODE WHEN THE MAIN POWER WAS RESUMED. THIS CAUSED THE BATTERY TO BE COMPLETELY DRAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMERIEUX BACT/ALERT MICROBIAL DETECTION SYSTEM BACT ALERT JTA BIOMERIEUX

    Patients

    Seq Age Sex Outcome Treatment
    1