BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 2922652 · Received December 27, 2012

    Report

    Report Number
    2031702-2012-00323
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    November 14, 2012
    Report Date
    December 27, 2012
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR STOPPED VENTILATING WITH AN AUDIBLE/VISUAL ALARM WHILE CONNECTED TO A PATIENT. THIS OCCURRED THREE TIMES. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED BEFORE BEING PLACED ON A BACK-UP VENTILATOR. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LTV VENTILATOR, CONTINUOUS/CBK CBK CAREFUSION 203, INC. LTV 950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR