BEUDAMED
    FDA Adverse Event Death Summary report: N

    JULIAN

    MDR report key: 3624460 · Received January 24, 2014

    Report

    Report Number
    9611500-2014-00008
    Event Type
    Death
    Date Received
    January 24, 2014
    Date of Event
    December 21, 2013
    Report Date
    January 23, 2014
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    BSZ
    PMA / PMN Number
    K983635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS INCONSPICUOUS IN A COMPLETE TEST PROVIDED AT THE USER FACILITY IN F/U OF THE EVENT. THE IN-DEPTH INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER TRIED TO RECONNECT A NEUROLOGIC TRAUMA PT TO THE JULIAN AFTER A CLINIC-INTERNAL TRANSPORT ASSISTED BY A TRANSPORT VENTILATOR. IT WAS NOT POSSIBLE TO BUILD-UP SUFFICIENT PRESSURE/VOLUME FOR RESUSCITATION OF THE PT. THE PT DIED IN THE COURSE OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57249 JULIAN ANESTHESIA WORKSTATION BSZ DRAEGER MEDICAL GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Death