BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NARKOMED

    MDR report key: 498613 · Received September 12, 2003

    Report

    Report Number
    2517967-2003-00117
    Event Type
    Injury
    Date Received
    September 12, 2003
    Date of Event
    February 9, 2001
    Report Date
    August 20, 2003
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    BSZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: DURING A PROCEDURE FOR REMOVAL OF A BRAIN TUMOR, THE ANESTHESIA MACHINE VENTILATOR REPORTEDLY STOPPED. THE ANESTHESIOLOGIST SWITCHED TO MANUAL VENTILATION ON THE MACHINE AND THEN CHOSE TO SWITCH TO A REPLACEMENT ANESTHESIA MACHINE. ACCORDING TO THE ORIGINAL REPORT THE PT MAINTAINED GOOD COLOR AND OXYGEN SATURATION THROUGHOUT THE PROCEDURE. NO INJURY REPORTED. IN 2003, DRAEGER MEDICAL, INC, OBTAINED REPORTED INFO THAT THE PT IS IN A COMA AND HAS BEEN DIAGNOSED WITH A BRIAN STEM HERNIATION. THE NEUROSURGEON ALLEGES THAT THE STOPPING OF THE VENTILATOR CAUSED THE BRAIN STEM HERNIATION BY CAUSING HYPOXIA. THE ANESTHESIOLOGIST ALLEGES THAT THE PT DID NOT EXPERIENCE A HYPOXIC EVENT AND THAT OXYGEN SATURATION STAYED BETWEEN 92% AND 99%.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| S