BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 5021816 · Received August 21, 2015

    Report

    Report Number
    2031702-2015-00177
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    July 12, 2015
    Report Date
    August 20, 2015
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE CENTER REPLACED THE VENTILATOR'S FLOW VALVE TO CORRECT THE REPORTED PROBLEM. A VISUAL INSPECTION REVEALED THAT THE FLOW VALVE STEPPER MOTOR BAND WAS BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR HAD LOW PIP WITH AN AUDIBLE ALARM WHILE ON THE PATIENT. THE PIP WAS APPARENTLY READING FROM 15 TO 3 CMH2O AND WAS CHANGING WITH EACH BREATH BY AS MUCH AS 12 CMH2O. IT WAS ALSO REPORTED THAT THE VENTILATOR WAS HOT TO THE TOUCH. WHEN DOING A PROPER OPERATION CHECKOUT AFTER REMOVING THE VENTILATOR FROM THE PATIENT, IT WAS NOTICED THAT THE VTE WAS LESS THAN 50% OF THE DELIVERED TIDAL VOLUME. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554663 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 900

    Patients

    Seq Age Sex Outcome Treatment
    1