BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3771191 · Received April 24, 2014

    Report

    Report Number
    2031702-2014-00107
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 18, 2014
    Report Date
    April 24, 2014
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K051767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR HAD NO TURBINE OPERATION WITH AN AUDIBLE DURING TESTING. THE VENTILATOR WAS NOT CONNECTED TO A PATIENT WHEN THE REPORTED PROBLEM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249688 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1000

    Patients

    Seq Age Sex Outcome Treatment
    1