BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 1984019 · Received January 14, 2011

    Report

    Report Number
    2031702-2011-00261
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Report Date
    January 14, 2011
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR'S TURBINE WENT INOPERATIONAL. THIS HAPPENED DURING A ROUTINE VENTILATOR CHECK. THE RESPIRATORY THERAPIST COULD NOT GET THE VENTILATOR TO CYCLE WITH A TEST LUNG AND COLD NOT HEAR THE TURBINE ON THE VENTILATOR. THE VENTILATOR WAS NOT CONNECTED TO A PT. IT IS UNK IF THE VENTILATOR ALARMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR