BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSK-TC ELECTRODE

    MDR report key: 6614528 · Received June 6, 2017

    Report

    Report Number
    3006630150-2017-02003
    Event Type
    Malfunction
    Date Received
    June 6, 2017
    Date of Event
    February 13, 2017
    Report Date
    February 13, 2017
    Manufacturer
    COSMAN MEDICAL
    Product Code
    GXI
    UDI-DI
    00813250010107
    PMA / PMN Number
    K050084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL #: CSK-TC10 LOT#: 080713 DESCRIPTION: CSK TC ELECTRODE, 10CM QUANTITY: 2 MODEL #:CSK-TC10 LOT#: 030613 DESCRIPTION: CSK TC ELECTRODE, 10CM QUANTITY: 1.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT MULTIPLE ELECTRODES WERE NO LONGER WORKING. DEVICE ANALYSIS REVEALED THAT ALL 3 ELECTRODES HAVE SHAFTS BROKEN FROM THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395051 CSK-TC ELECTRODE ELECTRODES GXI COSMAN MEDICAL CSK-TC10 080713 00813250010107

    Patients

    Seq Age Sex Outcome Treatment
    1