BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 2820484 · Received October 4, 2012

    Report

    Report Number
    2031702-2012-00239
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    August 16, 2012
    Report Date
    October 4, 2012
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    K060647
    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

    THIS MALFUNCTION REPORT IS BEING FILED OUTSIDE OF THE 30-DAY TIME FRAME.

    Description of Event or Problem · 1

    THE CAREFUSION SERVICE TECH REPORTED THAT THE VENTILATOR¿S TURBINE DID NOT TURN ON DURING SCHEDULED PREVENTATIVE MAINTENANCE. THE VENTILATOR WAS NOT CONNECTED TO A PT 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