BEUDAMED
    FDA Adverse Event Death Summary report: N

    NARKOMED

    MDR report key: 317748 · Received February 27, 2001

    Report

    Report Number
    2517967-2001-00012
    Event Type
    Death
    Date Received
    February 27, 2001
    Date of Event
    January 30, 2001
    Report Date
    February 27, 2001
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    BSZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: DURING CLOSURE AFTER A TEN HOUR MULTILEVEL BACK SURGERY, THE PT SUDDENLY BECAME BRADYCARDIC AND REQUIRED RESUSCITATION. BLOOD GASES WERE NORMAL AND THERE WAS NO MALFUNCTION OF THE ANESTHESIA EQUIPMENT. THE SURGERY WAS TO CORRECT SCOLIOSIS. THE PT REMAINED IN ICU, ON A VENTILATOR FOR SEVERAL DAYS AND SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7964 NARKOMED ANESTHESIA MACHINE BSZ DRAEGER MEDICAL, INC. 2B *

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Death