BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3171842 · Received May 23, 2013

    Report

    Report Number
    2031702-2013-00117
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Report Date
    May 22, 2013
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 TURNS ON AND OFF BY ITSELF. IT IS UNK IF THE VENTILATOR ALARMED OR IF IT WAS CONNECTED TO A PT WHEN THE REPORTED PROBLEM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228858 LTV VENTILATOR, CONTINUOUS/CBK CBK CAREFUSION 203, INC. LTV950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI