BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 4243558 · Received November 11, 2014

    Report

    Report Number
    2031702-2014-00244
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 1, 2014
    Report Date
    November 11, 2014
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS MAKING AN UNUSUAL NOISE AND APPEARED TO BE AUTO CYCLING WHILE CONNECTED TO A PATIENT. THE PATIENT WAS PLACED ON A BACK UP VENTILATOR WITH NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727770 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1150

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR