BEUDAMED
    FDA Adverse Event Death Summary report: N

    E200

    MDR report key: 279512 · Received May 22, 2000

    Report

    Report Number
    2023050-2000-00011
    Event Type
    Death
    Date Received
    May 22, 2000
    Date of Event
    March 1, 2000
    Report Date
    May 3, 2000
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    "INTUBATED PT, TRANSFERRED TO VENTILATOR, PROFOUND FALL IN OXYGEN SATURATION (COMPLICATED BY PERIPHERAL COOLNESS AND DECREASED OXIMETER PICK-UP), RESULTING IN PROFOUND BRADYCARDIA AND LOSS OF OUTPUT. RESUSCITATED, LATER BRAIN DEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E200 THE WAVE CBK NEWPORT MEDICAL INSTRUMENTS, INC. E200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death