BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMAGIQ

    MDR report key: 6135316 · Received November 30, 2016

    Report

    Report Number
    6135316
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    March 6, 2016
    Report Date
    October 28, 2016
    Manufacturer
    STILLE SURGICAL INC.
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT ON VASCULAR BED #13988986 FOR ORTHOPEDIC PROCEDURE. MUSHROOM ADDED TO BED AT REQUEST OF SURGICAL TEAM. IN THE MIDDLE OF THE PROCEDURE THE BED LOST POWER. NEITHER SURGICAL OR ANESTHESIA TEAMS WERE ABLE TO MOVE THE BED. ALL PLUGS WERE CHECK AND REPLUGGED IN. EQUIPMENT TECHNICIAN CALLED TO ROOM TO ASSIST. POWER WAS NOT ABLE TO BE RESTORED TO BED. BED ADJUSTMENT REQUIRED TO ADJUST C-ARM ANGLE. SURGICAL TEAM UNABLE TO SAFELY CONTINUE WITH PROCEDURE WITHOUT C-ARM ADJUSTMENT. WOUND CLOSED AND PATIENT SAFELY MOVED TO JACKSON TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786750 IMAGIQ TABLE, OPERATING-ROOM, ELECTRICAL GDC STILLE SURGICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1