BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWPORT E500 VENTILATOR

    MDR report key: 559855 · Received May 11, 2004

    Report

    Report Number
    2023050-2004-00008
    Event Type
    Malfunction
    Date Received
    May 11, 2004
    Date of Event
    March 14, 2004
    Report Date
    May 10, 2004
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    E500 WITH GDM AFTER NORMAL WORKING IN VC SIMV MODE VENTILATOR STOPPED GIVING BREATHS, GAS HAS GONE THRU THE EMERGENCY AIR INTAKE. THERE WAS NOT ANY ALARM. AFTER TURNING THE DEVICE OFF AND ON THE DEVICE WORKS NORMALLY BUT THE TRIGGER KNOB DOESN'T WORK PROPERLY, THERE IS NOT ANY RELATION WHEN ROTATING THE KNOB AND BECAUSE OF THAT THERE IS NO POSSIBILITY TO PERFORM TEST PROCEDURES IN SETUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWPORT E500 VENTILATOR VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS COMPLETE UNIT *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN