BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3233442 · Received July 18, 2013

    Report

    Report Number
    2031702-2013-00157
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    July 17, 2013
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Description of Event or Problem · 1

    THE VENTILATOR WAS RETURNED TO THE FIELD SERVICE CENTER FOR A SCHEDULED PREVENTATIVE MAINTENANCE. THE FIELD SERVICE CENTER REPORTED THAT THE VENTILATOR'S TURBINE WAS NOT WORKING. IT IS UNKNOWN IF THE VENTILATOR ALARMED WHEN THE REPORTED PROBLEM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334173 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 900

    Patients

    Seq Age Sex Outcome Treatment
    1