BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 2031481 · Received March 18, 2011

    Report

    Report Number
    2031702-2011-00299
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR SHUTS OFF WITH AN AUDIBLE ALARM AND THE SCREEN KEEPS BLINKING AND DOES NOT STOP SCROLLING. THERE ARE NO REPORTS OF PATIENT HARM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI