BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 2091327 · Received May 4, 2011

    Report

    Report Number
    2031702-2011-00093
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K051767
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR SHUT DOWN AND RESTARTED MULTIPLE TIMES WITH AN AUDIBLE ALARM. THE VENTILATOR DISPLAYED RESET. IT IS UNK IF THE VENTILATOR WAS CONNECTED TO A PT WHEN THE REPORTED PROBLEM OCCURRED. THE VENTILATOR WAS FROM A HOSPITAL ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LTV VENTILATOR, CONTINUOUS / CBK CBK CAREFUSION 203, INC LTV 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI