BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV1200

    MDR report key: 6068994 · Received November 1, 2016

    Report

    Report Number
    6068994
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    August 18, 2016
    Report Date
    October 28, 2016
    Manufacturer
    CAREFUSION 211, INC.. DBA CAREFUSION
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HOOKED UP TO THE TRANSPORT VENTILATOR; IMMEDIATELY THE VENTILATOR BEGAN ALARMING LOW PRESSURE AND TIDAL VOLUMES WERE >3000CC. BEGAN TROUBLE SHOOTING AND LOOKING OVER VENTILATOR WITHOUT ANY OBVIOUS SOLUTION. PATIENT WAS DISCONNECTED FROM VENTILATOR AND BAGGED. PATIENT PLACED ON LTV 1000 VENTILATOR. PATIENT'S VITAL SIGNS REMAINED STABLE. NO HARM WAS DONE TO THE PATIENT AND NO COMPLICATIONS WERE CAUSED FROM THIS. DEVICE HAS BEEN PLACED OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720840 LTV1200 VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION 211, INC.. DBA CAREFUSION LTV1200

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other