BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3132363 · Received May 1, 2013

    Report

    Report Number
    2031702-2013-00097
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    March 25, 2013
    Report Date
    May 1, 2013
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PT WAS PLACED ON NOC VENTILATION, IT WAS NOTED THAT THE VENTILATOR WAS TRYING TO GIVE A BREATH BUT WAS NOT DELIVERING ONE. THE PT WAS REMOVED FROM THE VENTILATOR AND PLACED ON ANOTHER VENTILATOR. NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190947 LTV VENTILATOR, CONTINUOUS / CBK CBK CAREFUSION 203, INC LTV 1150 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR