BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 5019606 · Received August 20, 2015

    Report

    Report Number
    2031702-2015-00176
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    July 13, 2015
    Report Date
    August 20, 2015
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR'S TURBINE WAS REPLACED TO CORRECT THE REPORTED PROBLEM. THE EVALUATION OF THE TURBINE HAS NOT BEEN COMPLETED YET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR'S TURBINE DID NOT ROTATE WITH AN AUDIBLE ALARM. THE REPORTED PROBLEM WAS IDENTIFIED DURING ROUTINE MAINTENANCE AND THE VENTILATOR WAS NOT CONNECTED TO A PATIENT WHEN THE REPORTED PROBLEM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551260 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1200

    Patients

    Seq Age Sex Outcome Treatment
    1