BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABYLOG

    MDR report key: 3820075 · Received April 16, 2014

    Report

    Report Number
    3820075
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 16, 2014
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY THERAPIST WENT TO USE VENTILATOR AND FOUND THAT THE HOSPITAL CONFIGURATION WAS GONE. THE MANUFACTURER TOLD ME TO SEND EVENT LOGS OVER TO THEM. I SENT THE EVENT LOG AND HERE IS THE RESPONSE: I DID SEE ERROR CODE 000001.00002 = S16 CORE MM/DD AT 3:31.ERROR = THE SYSTEM IS NOT READY FOR A PERIOD OF 8 SECONDS. THE SYSTEM HAS PERFORMED A RESTART.POSSIBLE CAUSES = SOFTWARE MODULE S16 HAS DETECTED AN ERROR AND REQUESTED A SYSTEM RESTART. ERRORS IN OTHER HARDWARE MODULES MAY HAVE CAUSED THIS CODE TO BE GENERATED.ERROR CODE 000256.00002 AT 3:36.ERROR = GENERAL ERROR IN COMMUNICATION WITH M10 NODE CONTROLLER. THE NODE CONTROLLER AFFECTED IS INDICATED IN THE INFO LOG FREE TEXT. THERE MAY BE MULTIPLE NODE CONTROLLERS. NO COMMUNICATION POSSIBLE BETWEEN TOP LEVEL AND SUBCOMPONENT, OR COMMUNICATION ERROR. POSSIBLE CAUSES = M10 NODE CONTROLLER IS DAMAGED OR ERROR IN M10 FIRMWARE IN MODULE. THE CABLE CONNECTION WAS CUT. INCOMPATIBLE M10 NODE CONTROLLER SOFTWARE VERSIONS.IT IS RECOMMENDED TO REINSTALL THE SOFTWARE TO THE M16. CHECK THE CABLE BETWEEN THE C500 AND VN500.IT COULD POSSIBLY LEAD TO THE REPLACEMENT OF THE M16 OR THE C500.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233876 BABYLOG VENTILATOR CBK DRAEGER MEDICAL SYSTEMS, INC. VN500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *