BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM 2 SYSTEM

    MDR report key: 3202013 · Received June 27, 2013

    Report

    Report Number
    3006524618-2013-00260
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K071709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE USING A QUANTUM 2 SYSTEM, THE DISPLAY SCREEN FOR THE UNIT WAS NOT WORKING PROPERLY. THIS DEFICIENCY RESULTED IN A LONG SURGICAL DELAY AND EVENTUALLY THE PROCEDURE WAS CANCELED. THERE WAS NO FURTHER INFORMATION PROVIDED REGARDING PATIENT COMPLICATIONS OR RESCHEDULING OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292168 QUANTUM 2 SYSTEM OPERATOR CONSOLE, DIATHERMY UNIT GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other