BEUDAMED
    FDA Adverse Event Death Summary report: N

    E200

    MDR report key: 122743 · Received September 26, 1997

    Report

    Report Number
    2023050-1997-00005
    Event Type
    Death
    Date Received
    September 26, 1997
    Date of Event
    September 16, 1997
    Report Date
    September 23, 1997
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WAVE VENTILATOR HAS NOT BEEN FUNCTIONING PROPERLY. THE DOCTORS OF THE HOSP ARE VERY ANGRY BECAUSE ONE OF THE PTS (A SMALL BABY) HAS DIED DUE TO VENTILATOR MALFUNCTIONING. VENTILATOR GIVING ERROR MESSAGE "P6". AFTER SWITCHING OFF AND ON, THE UNIT WORKS FOR SOMETIME AND AGAIN DISPLAYS THE SAME ERROR MESSAGE. MESSAGE GIVEN IN SERVICE MANUAL AS "NOT USED". RESEATED THE PCBS, BUT NO CHANGE. VENTILATOR GIVING CONTINUOUS MIXER ALARM. AFTER OPENING THE MIXER, FOUND TWO CHECK VALVES AT THE BASE QUITE HARD, WHEREAS THE OTHER TWO (IN FRONT) WERE SOFT. AFTER REPLACING THE HARD CHECK VALVES WITH SOFT ONES, THE MIXER STARTED WORKING SATISFACTORILY.

    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