BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 2000588 · Received February 1, 2011

    Report

    Report Number
    2031702-2011-00270
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 4, 2011
    Report Date
    February 1, 2011
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY LOW ALARM SOUNDED FOLLOWED BY SMOKE OUT OF POWER INPUT FOLLOWED BY 4-5 INCHES OF FLAME. THERE ARE NO ALLEGATIONS OF PATIENT HARM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI