BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT50 VENTILATOR

    MDR report key: 1459507 · Received August 24, 2009

    Report

    Report Number
    3003135857-2009-00013
    Event Type
    Malfunction
    Date Received
    August 24, 2009
    Date of Event
    June 3, 2009
    Report Date
    July 28, 2009
    Manufacturer
    FLIGHT MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K992133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AFTER THE DUAL PAC UPGRADE, DURING THE FINAL OVP, THE VENTILATOR SHUTDOWN ABRUPTLY. WHEN THE VENTILATOR WAS POWERED ON AGAIN, IT WOULD NOT INITIATE ITS LOADING SEQUENCE, GAVE CONSTANT ALARM AND WAS UNABLE TO BE SHUTDOWN BY CONVENTIONAL METHODS. THE MAIN BOARD WAS REPLACED AND THE VENTILATOR PASSED ALL TESTS AND THE PROBLEM WAS CORRECTED. IT WAS CONFIRMED THAT THIS FAILURE WAS DUE TO THE ISOLATED FAULTY MAIN BOARD. THE VENTILATOR WAS RE-CALIBRATED AND PERFORMED AN OVP; IT MET ALL REQUIRED SPECIFICATIONS. THE MAIN BOARD IN QUESTION WILL BE FORWARDED TO THE MFR.

    Description of Event or Problem · 1

    DURING THE EVAL OF THE RETURNED VENTILATOR, THE VENTILATOR SHUT DOWN ABRUPTLY AT THE TIME OF PERFORMING THE FINAL OPERATION VERIFICATION PROCEDURE (OVP). IT WAS CONFIRMED THAT THIS FAILURE WAS DUE TO THE ISOLATED FAULTY MAIN BOARD. IF THIS FAILURE WERE TO RECUR, IT WOULD LIKELY CAUSE OR CONTRIBUTED TO A SERIOUS INJURY BECAUSE THE VENTILATOR WOULD GIVE AN ALARM, HOWEVER, IT WOULD NOT GIVE WARNING BEFORE ALARMING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA