BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 2212175 · Received July 8, 2011

    Report

    Report Number
    2031702-2011-00147
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Report Date
    July 7, 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
    CO, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS HAVING RESET ISSUES, THE VENTILATOR WENT INOP, AND WOULD HAVE TO BE RESTARTED VIA ON STANDBY BUTTON. IT IS UNKNOWN IF THE VENTILATOR WAS ON A PATIENT WHEN THE REPORTED PROBLEM OCCURRED.

    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