BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 2830447 · Received October 10, 2012

    Report

    Report Number
    2031702-2012-00255
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Report Date
    October 9, 2012
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TESTING THE VENTILATOR AFTER COMPLETING THE SCHEDULED PREVENTATIVE MAINTENANCE, THE TURBINE WOULD NOT START UP. 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 900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA