BEUDAMED
    FDA Adverse Event Death Summary report: N

    E150

    MDR report key: 192639 · Received October 19, 1998

    Report

    Report Number
    2023050-1998-00007
    Event Type
    Death
    Date Received
    October 19, 1998
    Date of Event
    October 9, 1998
    Report Date
    October 14, 1998
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BREEZE VENTILATOR CONNECTED TO FEMALE, FIVE MONTH OLD PT (WEIGHT 6 KG). PT WAS CONNECTED FOR 15 DAYS, IN PRESSURE CONTROL MODE WITH POSITIVE INSPIRATORY PRESSURE - 35 CM WATER; FLOW - 15 LITERS PER MINUTE; I.T. - 0.5 SEG; FRACTION OF INSPIRED OXYGEN - 40%; RATE - 30 BREATHS PER MINUTE; POSITIVE END EXPIRATORY PRESSURE - 5 CM WATER. THE PT WAS RELAXING AND HER VITAL SIGNS WERE: ALVEOLAR OXYGEN TENSION - UNKNOWN; OXYGEN SATURATION - 92 TO 94%; ALVEOLAR CARBON DIOXIDE TENSION - 32 TO 36; HIGH BLOOD PRESSURE; PULSE RATE - 130 BREATHS PER MINUTE; ELECTROCARDIOGRAM NORMAL; CONSCIOUS WITH EFFORT, BUT THEN RELAXING. THE NOISE WAS ALWAYS PRESENT. WHEN THE PRESSUE DROPPED, THE ALARM TURNED ON AND THE DOCTOR CHANGED THE EQUIPMENT TO ANOTHER VENTILATOR, THEN HE CONNECTED BACK TO BREEZE AGAIN. PT HAD PULMONARY HEMORRAGIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E150 THE BREEZE CBK NEWPORT MEDICAL INSTRUMENTS, INC. E150 *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Death