BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3250616 · Received July 26, 2013

    Report

    Report Number
    2031702-2013-00160
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Report Date
    July 26, 2013
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WOULD NOT CYCLE A BREATH WITH AN AUDIBLE ALARM AND IT ALSO FAILED THE LEAK TEST. THE VENTILATOR WAS NOT ON A PATIENT WHEN THE REPORTED PROBLEM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349837 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 950

    Patients

    Seq Age Sex Outcome Treatment
    1