BEUDAMED
    FDA Adverse Event Death Summary report: N

    E200

    MDR report key: 109371 · Received July 25, 1997

    Report

    Report Number
    2023050-1997-00004
    Event Type
    Death
    Date Received
    July 25, 1997
    Date of Event
    July 17, 1997
    Report Date
    July 24, 1997
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    VENTILATOR SUDDENLY FAILED "DURING THE USE FOR REANIMATING A MAN WHO GOT DROWNED...THEY COULDN'T SAVE HIM." THEY HAVE REMOVED ALL MOVABLE BOARDS, CLEANED THE CONNECTORS, REINSERTED AGAIN. THERE IS QUITE BIG DAMAGE ON THE FRONT PANEL, ABOUT 1 CM BENT TOWARD INSIDE. ALSO FIO2 KNOB DOESN'T FUNCTION PROPERLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death