BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEWPORT HT50

    MDR report key: 451994 · Received April 2, 2003

    Report

    Report Number
    2023050-2003-00005
    Event Type
    Death
    Date Received
    April 2, 2003
    Date of Event
    March 3, 2003
    Report Date
    March 4, 2003
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT HAD BEEN DECEASED BY DISCONNECTION OF THE VENTILATOR. A NURSE HAS FOUND THAT PATIENT WHO WAS IN THE HOSPITAL FOR ALS HAS DECEASED WHEN THE NURSE CAME TO CHANGE THE ALIMENTATION LINE. ACCORDING TO THE HOSPITAL THE PATIENT HAS USED TRACHEOTOMY TUBE TO TREAT A VENTILATION AND THE NURSE SAID WHEN THEY CAME TO THE PATIENT ROOM THE NURSE SEEMED THAT THE VENTILATOR HAD BEEN DISCONNECTED. THEY SAY THAT THE ALARM DID NOT BEEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWPORT HT50 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death