BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWPORT HT50 VENTILATOR

    MDR report key: 1020765 · Received February 5, 2008

    Report

    Report Number
    2023050-2008-00007
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    January 3, 2008
    Report Date
    January 11, 2008
    Manufacturer
    FLIGHT MEDICAL LTD.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNIT "FROZE" WHILE DELIVERING THERAPY TO THE PT. VENT BEGAN TO "SCREACH" INTERNALLY AND VERY LOUDLY WITH AUDIO ALARMS AND WENT TO STANDBY MODE AND SHUT DOWN AIR DELIVERY. VENT WOULD NOT TURN OFF OR RESUME VENTILATION THERAPY. PLEASE NOTE THERE WAS NO SERIOUS INJURY OR DEATH IN THIS INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN