BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 3122549 · Received May 17, 2013

    Report

    Report Number
    2031702-2013-00110
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 19, 2013
    Report Date
    September 12, 2013
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPONTANEOUS BREATHING TRIAL WAS TERMINATED DUE TO THE APNEA INTERVAL BEING MET. THE EVENT TRACE ALSO INDICATES THAT THE VENTILATOR HAD TWO TURBINE ZERO ALARM CONDITIONS ONE MINUTE FOLLOWING THE TERMINATION OF THE SPONTANEOUS BREATHING TRIAL (TBN ZERO).

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    NO PATIENT HARM REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR'S TURBINE STOPPED WITH AN AUDIBLE/VISUAL ALARM WHILE CONNECTED TO A PT. THE PT DESATURATED AND WAS PLACED ON A BACKUP VENTILATOR. ACCORDING TO THE CUSTOMER, THE HOME CARE AID WAS PRESSING BUTTONS ON THE VENTILATOR TO SHOW THE PT HOW SCREEN SCROLLING WORKED AND THE VENTILATOR BEGAN ALARMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219496 LTV VENTILATOR, CONTINUOUS / CBK CBK CAREFUSION 203, INC LTV 1150 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Required Intervention