BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3771212 · Received April 24, 2014

    Report

    Report Number
    2031702-2014-00106
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR HAD NO TURBINE OPERATION. IT IS UNKNOWN IF THE VENTILATOR ALARMED OR IF IT WAS CONNECTED TO A PATIENT WHEN THE REPORTED PROBLEM OCCURRED. THE RESPIRATORY THERAPIST HAD REPORTED THAT THE VENTILATOR WAS PICKED UP FROM THE PATIENT'S HOME BECAUSE IT WAS GETTING VERY HOT TO THE TOUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249699 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1150

    Patients

    Seq Age Sex Outcome Treatment
    1