BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT50 VENTILATOR

    MDR report key: 1182203 · Received July 15, 2008

    Report

    Report Number
    2023050-2008-00052
    Event Type
    Malfunction
    Date Received
    July 15, 2008
    Date of Event
    April 8, 2008
    Report Date
    June 26, 2008
    Manufacturer
    FLIGHT MEDICAL LTD.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING THE USE ON THE PT, ALL RED LED WERE LIT AND THEN THE UNIT STOPPED VENTILATING. PRESSING THE RESET BUTTON FIXED THE PROBLEM. THE UNIT WAS RUNNING ON AC POWER. PLEASE NOTE THAT THERE WAS NO SERIOUS INJURY IN THE REPORTED CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN