BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3803282 · Received May 9, 2014

    Report

    Report Number
    2031702-2014-00121
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED BEYOND THE 30 DAY REPORTING TIMELINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS LOSING POWER AND TURNING OFF WITH AN AUDIBLE ALARM DURING A SCHEDULED PREVENTATIVE MAINTENANCE. THE VENTILATOR WAS NOT CONNECTED TO A PATIENT WHEN THE REPORTED PROBLEM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280650 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 950

    Patients

    Seq Age Sex Outcome Treatment
    1