BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3063839 · Received April 3, 2013

    Report

    Report Number
    2031702-2013-00067
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    April 3, 2013
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING BENCH TESTING, THE VENTILATOR WAS POWERED ON AND WAS NOT BLOWING OUT AIR PROPERLY. ALL OF THE SETTINGS WERE CHECKED BUT STILL NO AIR WAS COMING OUT. THE VENTILATOR WAS NOT CONNECTED TO A PT WHEN THE REPORTED PROBLEM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135641 LTV VENTILATOR, CONTINUOUS /CBK CBK CAREFUSION 203, INC LTV 950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA