BEUDAMED
    FDA Adverse Event Death Summary report: N

    NARKOMED

    MDR report key: 911632 · Received September 11, 2007

    Report

    Report Number
    2517967-2007-00005
    Event Type
    Death
    Date Received
    September 11, 2007
    Date of Event
    August 13, 2007
    Report Date
    August 13, 2007
    Manufacturer
    DRAGER MEDICAL, INC. (MT-A)
    Product Code
    BSZ
    PMA / PMN Number
    K930351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY A DRAEGER SERVICE TECHNICIAN. A COMPLETE PREVENTIVE MAINTENANCE TEST WAS RUN ON THE NARKOMED 2C MACHINE AND THE MACHINE PASSED THE PREVENTIVE MAINTENANCE TESTS IN ACCORDANCE WITH DRAEGER MEDICAL, INC. SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN THE OR FOR A PERMACATH INSERTION PROCEDURE. THE PATIENT WAS GIVEN A LOCAL ANESTHETIC AND WAS NOT INTUBATED. THEY WERE HAVING TROUBLE INSERTING THE IV LINE INTO THE BLOOD VESSEL. THEY HAD TRIED ONE SIDE AND WAS UNSUCCESSFUL. AT SOME POINT, WHILE ATTEMPTING TO INSERT THE IV LINE INTO THE OTHER SIDE, THE PATIENT CODED. THE PATIENT WAS THEN CONNECTED TO THE NM2C MACHINE. THE PATIENT COULD NOT BE REVIVED AND EXPIRED. AT THE TIME OF THE REPORT, THE CAUSE FOR THE PATIENT EXPIRING WAS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NARKOMED ANESTHESIA MACHINE BSZ DRAGER MEDICAL, INC. (MT-A) 2C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death