BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 2190637 · Received July 29, 2011

    Report

    Report Number
    2031702-2011-00159
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    THE VENTILATOR WAS ORIGINALLY RETURNED TO THE FIELD SERVICE CENTER FOR ROUTINE PREVENTATIVE MAINTENANCE. IT WAS REPORTED BY THE FIELD SERVICE CENTER THAT DURING SERVICE, THE VENTILATOR HAD A DISC/SENSE ALARM AND THE TURBINE WAS NOT FUNCTIONING. THE VENTILATOR WAS NOT CONNECTED TO 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA