BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM SYSTEM

    MDR report key: 3112107 · Received May 7, 2013

    Report

    Report Number
    3006524618-2013-00172
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 9, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K071709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE QUANTUM SYSTEM WAS TAKEN OUT OF SERVICE AFTER THE FACILITY BEGAN EXPERIENCING ISSUES WITH WANDS. LIMITED INFORMATION CONCERNING SPECIFIC EVENTS WAS PROVIDED, HOWEVER NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199898 QUANTUM SYSTEM OPERATOR CONSOLE, DIATHERMY UNIT GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other