BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYS 2000 FOOTSWITCH

    MDR report key: 3915460 · Received June 5, 2014

    Report

    Report Number
    3006524618-2014-00171
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 8, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K011634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPINE PROCEDURE USING A SYS 2000 FOOTSWITCH, THE FOOTSWITCH STOPPED WORKING DURING THE MIDDLE OF THE PROCEDURE. THE PROCEDURE HAD TO BE STOPPED AND RESCHEDULED, AS THERE WAS NO BACKUP FOOTSWITCH AVAILABLE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328867 SYS 2000 FOOTSWITCH OPERATOR CONSOLE, DIATHERMY UNIT GEI ARTHROCARE CORPORATION 11403

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other