BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3182826 · Received June 11, 2013

    Report

    Report Number
    2031702-2013-00129
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    April 18, 2013
    Report Date
    July 2, 2013
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    K051767
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE VENTILATOR STOPPED VENTILATING THE PT WITH AN AUDIBLE ALARM. IN A F/U CALL TO THE CUSTOMER, THEY STATED THAT THE RT FOUND THE PT WITH THEIR TUBING DISCONNECTED AND AN AUDIBLE ALARM. NO PT HARM REPORTED AS THE PT WAS ABLE TO BREATHE SPONTANEOUSLY. THE PT WAS RE-CONNECTED TO THE VENTILATOR. A WRITTEN REPORT WAS RECEIVED FROM THE CUSTOMER THAT STATED THE PT WAS CONNECTED TO THE VENTILATOR AND THE VENTILATOR ALARMED "DISCONNECTED". THE CONNECTIONS WERE CHECKED MULTIPLE TIMES BY MULTIPLE STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264810 LTV VENTILATOR, CONTINUOUS / CBK CBK CAREFUSION 203, INC. LTV 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1