BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 1894243 · Received November 3, 2010

    Report

    Report Number
    2031702-2010-00218
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE VENTILATOR PT CIRCUIT SENSE LINES WERE MOVED, THE TURBINE WOULD STOP BLOWING AIR WHILE CONNECTED TO A PT. THE CUSTOMER TRIED A DIFFERENT PT CIRCUIT AND THE SAME PROBLEM OCCURRED. THERE WAS NO AUDIBLE ALARM. NO PT HARM REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI