BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMERIEUX BACTERIAL MICROBIAL DETECTION SYSTEM

    MDR report key: 2462509 · Received February 10, 2012

    Report

    Report Number
    MW5024258
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Date of Event
    January 27, 2012
    Report Date
    February 10, 2012
    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 SYSTEM PRESENTED WITH CODE 710 AND MESSAGE "INCUBATOR MODULE TEMPORARILY UNAVAILABLE WHILE POWER UP INITIALIZATION TAKES PLACE. THE CODE THEN WENT AWAY ONLY TO REPEAT AGAIN SEVERAL MORE TIMES. ERROR CODE 1 "POWER FAULT IN INCUBATION MODULE" ALSO APPEARED. INCUBATOR #5 ASSOCIATED WITH THE CONTROLLER CONTAINED CULTURE BOTTLES FROM 32 APHERESIS COLLECTIONS. CULTURE BOTTLES HAD TO BE RELOCATED TO ANOTHER INCUBATOR. PER THE BIOMERIEUX TECH, THE VOLTAGE ON THE POWER SUPPLY WAS OUT OF TOLERANCE CAUSING THE POWER INTERRUPTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1