BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3131530 · Received May 14, 2013

    Report

    Report Number
    2031702-2013-00109
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS GOING INTO A RESET CONDITION WITH A CONSTANT AUDIBLE ALARM. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214107 LTV VENTILATOR, CONTINUOUS / CBK CBK CAREFUSION 203, INC LTV 950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI