BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIOBE MAGNETIC NAVIGATION SYSTEM

    MDR report key: 1372752 · Received February 20, 2009

    Report

    Report Number
    3003084417-2009-00001
    Event Type
    Malfunction
    Date Received
    February 20, 2009
    Date of Event
    January 26, 2009
    Report Date
    February 20, 2009
    Manufacturer
    STEREOTAXIS, INC.
    Product Code
    NDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THIS EVENT REVEALED THAT THE SIGNAL FOR THE MAGNETIC VECTOR ORIGINATED AT THE TOUCH SCREEN LOCATED IN THE PROCEDURE ROOM. AN EXAMINATION OF THE TOUCH SCREEN REVEALED THE PRESENCE OF A LARGE SCRATCH IN THE SURFACE OF THE SCREEN AT APPROXIMATELY THE 7:00 POSITION. THE DAMAGE WAS SUFFICIENT TO CAUSE INTERMITTENT SIGNALS TO BE SENT TO THE MAGNET POSITIONERS, CAUSING THE CHANGE IN VECTOR DIRECTION. THE TOUCH SCREEN WAS DISCONNECTED, PER THE CUSTOMER'S REQUEST. EVALUATION SUMMARY: BACKGROUND: EVALUATION WAS PERFORMED ON NIOBE SYSTEM ((B)(4)) LOCATED AT (B)(6). MALFUNCTION WAS REPORTED WHEREBY THE MAGNETIC FIELD VECTOR WOULD INTERMITTENTLY CHANGE TO THE 7:00 POSITION WITHOUT USER INPUT. EVALUATION: THE NIOBE LOG FILES WERE RETRIEVED BY THE NAVIGANT SOFTWARE ENGINEERING MANAGER AND EXAMINED. THE LOG FILES COVERED THE TIME FRAME OF THE REPORTED MALFUNCTION. APPARENTLY THE INPUT WAS ORIGINATING FROM THE TOUCH SCREEN. THERE WERE SEVERAL FIELD APPLICATIONS SENT FROM THE TOUCHSCREEN TO NIOBE FROM 15:44 TO 16:35. THE FIELD DIRECTIONS CORRESPONDED APPROX TO THE 7 O'CLOCK FIELD DIRECTION. OTHER USER INTENDED FIELDS WERE BEING APPLIED AT EACH OF THE TIMES THAT A REQUEST CAME IN FROM THE TOUCHSCREEN, RESULTING IN THE OBSERVED JUMP/CHANGE IN VECTOR DIRECTION. A STEREOTAXIS FIELD ENGINEER EXAMINED THE NIOBE SYSTEM AT THE CUSTOMER SITE. A VISUAL INSPECTION REVEALED A DEEP SCRATCH ON THE TOUCHSCREEN AT APPROXIMATELY THE 7:00 POSITION. APPARENTLY THE SCRATCH WAS CAUSING THE ERRANT VECTOR CHANGE BECAUSE REPEATED OCCURRENCES OF THE VECTOR CHANGING TO THE 7:00 POSITION WERE OBSERVED BY FIELD ENGINEER. CONCLUSION: THE ROOT CAUSE OF THE REPORTED MALFUNCTION WAS TOUCH SCREEN DAMAGE, PRESUMABLY CAUSED BY CUSTOMER FACILITY PERSONNEL. NOTE: THE DAMAGED TOUCH SCREEN WAS REMOVED BY CUSTOMER FACILITY PERSONNEL. IT WAS NOT USED TO PERFORM PROCEDURES BECAUSE IT IS ONLY USED IN IC/CRT PROCEDURES, WHICH ARE NOT PERFORMED AT THIS USER FACILITY.

    Description of Event or Problem · 1

    DURING AN ELECTROPHYSIOLOGY PROCEDURE, A BIOMEDICAL TECHNICIAN CALLED TO REPORT MAGNETIC VECTOR CHANGES TO APPROXIMATELY THE 7:00 POSITION WITHOUT INTENTIONAL INPUT FROM THE USER. THE VECTORS WERE CORRECTED AND THE PROCEDURE CONTINUED. THE VECTOR CHANGE OCCURRED A THIRD TIME, MOVING TO THE SAME 7:00 POSITION, THIS TIME DURING AN RF ENERGY APPLICATION. THE PHYSICIAN IMMEDIATELY DISCONTINUED THE RF APPLICATION. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIOBE MAGNETIC NAVIGATION SYSTEM STEERABLE CATHETER CONTROL SYSTEM NDQ STEREOTAXIS, INC. 001-006100-1

    Patients

    Seq Age Sex Outcome Treatment
    1