BEUDAMED
    FDA Adverse Event Other Summary report: N

    HT50 VENTILATOR

    MDR report key: 2141325 · Received June 16, 2011

    Report

    Report Number
    3003135857-2011-00006
    Event Type
    Other
    Date Received
    June 16, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    FLIGHT MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K082724
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE VENTILATOR STOPPED VENTILATING. THEN, THE PATIENT'S MOTHER TRIED TURNING THE VENTILATOR OFF AND ON TO RE-START IT. HOWEVER, THE VENTILATOR WOULD NOT ALLOW ANY SETTING CHANGES AND THE AUDIBLE ALARM KEPT SOUNDING CONTINUALLY. WHEN THE VENTILATOR WAS BACK ON AGAIN LATER, "SYSTEM ERROR" MESSAGE WAS SHOWN IN THE LED SCREEN. THE PATIENT WAS AMBU BAGGED AND THEN SWITCHED TO THE BACK-UP VENTILATOR. PLEASE NOTE THAT THERE WAS NO PERMANENT INJURY IN THIS CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention