BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV1200

    MDR report key: 6069007 · Received November 1, 2016

    Report

    Report Number
    6069007
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    August 7, 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

    DURING TRANSPORT OF PATIENT, THE VENTILATOR BEGAN TO ALARM "LOW PRESSURE" AND "LOW MINUTE VENTILATION." PATIENT WAS TAKEN OFF VENTILATOR AND MANUALLY BAGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720111 LTV1200 VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION 211, INC.. DBA CAREFUSION LTV1200

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other UNKNOWN.