BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 4916615 · Received July 15, 2015

    Report

    Report Number
    2031702-2015-00137
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    April 26, 2015
    Report Date
    July 15, 2015
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FAMILY NOTICED SMOKE COMING FROM THE VENTILATOR PIGTAIL. BEFORE THE FAMILY COULD GET THE POWER CORD UNPLUGGED FROM THE WALL OUTLET, THE FAMILY NOTICED A FLAME FOR A BRIEF PERIOD OF TIME. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON A BACK-UP VENTILATOR. THE VENTILATOR PIGTAIL AND THE POWER CORD HAD MELTED TOGETHER. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459781 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 950

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR