BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWPORT HT50 VENTILATOR

    MDR report key: 1002968 · Received February 11, 2008

    Report

    Report Number
    2023050-2008-00009
    Event Type
    Malfunction
    Date Received
    February 11, 2008
    Date of Event
    December 28, 2007
    Report Date
    January 14, 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

    AS REPORTED, UNIT FAILED WITH "10V POWER FAIL" ALERT DISPLAYED. UNIT IMMEDIATELY SHUTDOWN WITHOUT ANY AUDIO ALARMS. VENT WAS NOT ON A PT BUT FAILED DURING SET-UP PROCEDURE. UNIT WAS PLUGGED IN AND OPERATING ON A/C POWER AT THE TIME OF INCIDENT. PLEASE NOTE, THERE WAS NO PT INVOLVEMENT IN THIS CASE.

    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 44 YR