BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 1890503 · Received October 28, 2010

    Report

    Report Number
    2031702-2010-00215
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    September 22, 2010
    Report Date
    October 28, 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
    AR, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING, THE VENTILATOR FAILED THE LEAK TEST, THE TURBINE WOULD NOT MOVE, AND THERE WAS NO FLOW. THE VENTILATOR WAS NOT CONNECTED TO A PT WHEN THE REPORTED PROBLEM OCCURRED.

    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 58 YR