BEUDAMED
    FDA Adverse Event Death Summary report: N

    E200

    MDR report key: 204822 · Received December 31, 1998

    Report

    Report Number
    2023050-1998-00008
    Event Type
    Death
    Date Received
    December 31, 1998
    Date of Event
    November 25, 1998
    Report Date
    December 15, 1998
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE VENTILATOR AUTO TRIGGERS AND DISPLAYS A DRIFTING BASE LINE ON THE MONITOR, IRRESPECTIVE OF SENSITIVITY AND OTHER SETTINGS. TECHNICIAN SUSPECTS FAULTY TRANSDUCERS.

    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