BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3771186 · Received April 24, 2014

    Report

    Report Number
    2031702-2014-00105
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 24, 2014
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Description of Event or Problem · 1

    THE VENTILATOR WOULD NOT TURN ON WITHOUT AN EXTERNAL POWER SOURCE. THE CAREFUSION SERVICE TECH REPORTED THAT THE VENTILATOR HAD A SEIZED TURBINE WITH AN AUDIBLE ALARM.THE PROBLEM WAS FOUND DURING SERVICE AND WAS NOT CONNECTED TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250038 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1200

    Patients

    Seq Age Sex Outcome Treatment
    1