BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWPORT HT50 VENTILATOR

    MDR report key: 1020780 · Received February 5, 2008

    Report

    Report Number
    2023050-2008-00006
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    January 8, 2008
    Report Date
    January 9, 2008
    Manufacturer
    FLIGHT MEDICAL LTD.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, PT WAS USING A NMI DISPOSABLE; NON-HEATED "J" CIRCUIT. DURING TRANSFER FROM THE HOSP TO AN AMBULANCE, THE UNIT WAS UNPLUGGED FROM AC AND OPERATING ON INTERNAL BATTERY TO THE AMBULANCE. ONCE INSIDE THE VEHICLE THE UNIT WAS PLUGGED BACK INTO AC AND THE O2 BLENDER WAS UNHOOKED FROM THE EXTERNAL TANKS AND PLUGGED INTO THE AMBULANCE'S O2 FLOW METER (GLASS TUBE WITH BALL BEARING INDICATOR). THE UNIT WAS DETACHED FROM THE CART AND PUT INTO THE AMBULANCE: AT THIS TIME, IT STOPPED CYCLING (DELIVERING BREATHS). THE RT REMOVED THE PT FROM THE UNIT IMMEDIATELY AND STARTED BAGGING HER. THE UNIT WAS SHUT OFF AND A TEST LUNG WAS ATTACHED TO THE CIRCUIT. WHEN THE UNIT WAS POWERED BACK ON; THE UNIT GAVE A "SYSTEM ERROR" MESSAGE. THE UNIT WAS SHUT OFF AND TURNED BACK ON AGAIN; BUT A "MOTOR FAULT" ERROR WAS GIVEN THIS TIME. THE PT WAS BAGGED THE ENTIRE AMBULANCE RIDE. PLEASE NOTE THERE WAS NO DEATH OR SERIOUS INJURY IN THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWPORT HT50 VENTILATOR VENTILLATOR CBK FLIGHT MEDICAL LTD. HT50-H1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR