BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2445744 · Received February 3, 2012

    Report

    Report Number
    2445744
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Date of Event
    January 10, 2012
    Report Date
    February 3, 2012
    Manufacturer
    MEDTRONIC CARDIAC SURGERY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THERE WAS A BREAK IN FLUID TUBING THAT ATTACHED TO THE GRAY TUBING LEADING TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CARDIOBLATE BIPOLAR GEI MEDTRONIC CARDIAC SURGERY * N959

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR