BEUDAMED
    FDA Adverse Event Death Summary report: N

    NARKOMED

    MDR report key: 518225 · Received March 25, 2004

    Report

    Report Number
    2517967-2004-00051
    Event Type
    Death
    Date Received
    March 25, 2004
    Date of Event
    February 25, 2004
    Report Date
    March 24, 2004
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    BSZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: DURING MECHANICAL VENTILATION, THE PT WAS NOT EXHALING. THE DOCTOR NOTED THAT HE COULD SEE CHEST RISE BUT NOT FALL. THE PT'S CHEST WAS OPENED AND HAND MASSAGE WAS PERFORMED ON THE HEART BUT THE DOCTOR INDICATED THAT THE HEART WAS ESSENTIALLY EMPTY AND THE PT COULD NOT BE RESUSCITATED. THE DOCTOR INDICATED THAT THE PT EXPIRED DUE TO THE MAJOR TRAUMA SUFFERED DURING A MOTORCYLE ACCIDENT. THE DOCTOR ALSO SAID THAT THE ANESTHESIA MACHINE HAD BEEN USED TWO DAYS PRIOR DURING A CASE INVOLVING A PT SUFFERIENG FROM A GUNSHOT WOUND TO THE CHEST. HE INDICATED THAT THERE WAS A LOT OF BLOOD RESULTING FROM THE CASE. HE SAID HE UNDERSTOOD THAT THE DEVICE WAS WIPED DOWN AND THE BREATHING CIRCUIT CHANGED BUT THOUGHT THAT PERHAPS BLOOD FROM THIS CASE HAD GOTTEN INTO THE EXHALATION SIDE OF THE BREATHING SYSTEM AND WAS CREATING AN OBSTRUCTION. THE DEVICE WAS USED AGAIN A FEW HOURS AFTER THIS REPORTED EVENT. REFERENCE MDR # 2517967-2004-00052.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NARKOMED ANESTHESIA MACHINE BSZ DRAEGER MEDICAL, INC. 2C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death