BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONAGHAN 225/SIMV VENTILATOR

    MDR report key: 90947 · Received May 9, 1997

    Report

    Report Number
    90947
    Event Type
    Injury
    Date Received
    May 9, 1997
    Date of Event
    August 29, 1996
    Report Date
    April 11, 1997
    Manufacturer
    MONAGHAN MEDICAL CORP.
    Product Code
    IKN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PLACED VENT ON POSTOP PT. PT WAS ASSESSED, OBSERVED NO VENTILATION AND VENT WAS MAKING A LOUD SOUND, LIKE AIR ESCAPING. REPLACED VENT WITH ANOTHER MACHINE. FIOMED FINDINGS, FOUND PRESSURE LINE INSIDE VENTILATOR FROM THE MANIFOLD TO THE VENTILATOR PORT HAD COME LOOSE. CONNECTED PRESSURE HOSE TO CORRECT PORT AND RAN CHECK OUT PROCEDURE. ADJUSTED ASSIST SENSITIVITY CONTROL CHECK OUT 2/4 PER SERVICE MANUAL. PASSED. SETTINGS TIDAL VOL 800, RATE 12, 02 100%, PRESSURE 38.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONAGHAN 225/SIMV VENTILATOR VENTILATOR IKN MONAGHAN MEDICAL CORP. 225-SIMV M4022

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention