BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 2760018 · Received September 20, 2012

    Report

    Report Number
    2031702-2012-00223
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Report Date
    September 20, 2012
    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, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEDWATCH MALFUNCTION REPORT IS BEING FILED OUTSIDE OF THE THIRTY-DAY TIME FRAME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE FIELD SERVICE TECHNICIAN THAT THE VENTILATOR WAS DUE FOR A 10K PM AND WOULD NOT FULLY POWER UP ON THE BENCH WITH RESET ALARMS. THE VENTILATOR WAS NOT ON A PT WHEN THE REPORTED PROBLEM OCCURRED. THE SERVICE REPORT STATED THAT THE VENTILATOR KEEPS SHUTTING OFF.

    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 NA