BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3201815 · Received July 2, 2013

    Report

    Report Number
    2031702-2013-00151
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 26, 2013
    Report Date
    July 2, 2013
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR HAD A FAULTY PATIENT ASSIST PORT AND CABLE. THE VENTILATOR WAS BEING TESTED AND ALARMED WHEN THE PATIENT CIRCUIT WAS DISCONNECTED. THE VENTILATOR WAS ALARMING BUT THE NURSE CALL STATION DID NOT ALARM. WHEN THE CABLE WAS REPLACED, THE LTV PATIENT ASSIST PORT WAS STILL NOT FUNCTIONING. MANY PEOPLE WERE IN THE ROOM WHEN THE PROBLEM OCCURRED SO PEOPLE WERE AWARE OF THE ALARM AND WERE ABLE TO ALERT THE NURSE. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301969 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1200

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR