BEUDAMED
    FDA Adverse Event Death Summary report: N

    E100I NEWPORT VENTILATOR

    MDR report key: 644903 · Received November 7, 2005

    Report

    Report Number
    2023050-2005-00052
    Event Type
    Death
    Date Received
    November 7, 2005
    Date of Event
    October 29, 2005
    Report Date
    November 2, 2005
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE VENTILATOR STOPPED DELIVERING GAS AT 8:15AM IN 2005 AND THE PT DIED 18 MINUTES LATER. THE DOCTOR SAID THAT AS THE PATIENT'S VITAL SIGN DID NOT CHANGE PRIOR AND AFTER THE INCIDENT, THEREFORE, THE HOSPITAL AND THE DOCTOR REPORTED THAT IT IS UNCLEAR WHETHER THERE WAS CORRELATION BETWEEN THE INCIDENT AND THE PATIENT'S DEATH. FLOW OF THE VENTILATOR WAS NOTED NORMAL. THE INCIDENT WAS ALSO DUPLICATED WITH THE OTHER BREATHING CIRCUIT. THE PT WAS CONNECTED TO THE VENTILATOR AT 4:00PM THE DAY BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E100I NEWPORT VENTILATOR VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E100I NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death