BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6142744 · Received December 2, 2016

    Report

    Report Number
    1723170-2016-03338
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    April 28, 2015
    Report Date
    December 2, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT AND WAS UNABLE TO REPLICATE THE REPORTED ISSUE. THE MEDTRONIC REPRESENTATIVE OPTED TO REPLACE THE GANTRY MOTION CONTROLLER, POSITIONER MOTION CONTROLLER AND POWER SWITCHING BOARD. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FULLY FUNCTIONAL. INVESTIGATION OF RETURNED SUSPECT GANTRY MOTION CONTROLLER POSITIONER CONFIRMED THE REPORTED SOUND ISSUE. INSTALLED GANTRY CONTROL BOX IN TEST IMAGING SYSTEM AND THE MOTION READIED. ALL MOTION OCCURRED WHEN PROMPTED, INCLUDING ROTATION, TILT, DOOR OPEN/CLOSE. WHILE DOOR OPEN/CLOSE IS OCCURRING A HIGH PITCHED WHINE IS EMITTED FROM GANTRY CONTROL BOX. IT DOES NOT INTERFERE WITH MOTION, HOWEVER THE AUDIBLE NOISE IS PRESENT. NO FUNCTIONAL PROBLEM FOUND. AUDIBLE WHINE OBSERVED. INVESTIGATION OF RETURNED SUSPECT POSITIONER MOTION CONTROLLER WAS UNABLE TO CONFIRM REPORTED PROBLEM. INSTALLED MOTION CONTROL BOX IN TEST IMAGING SYSTEM, MOTION CALIBRATION WAS SUCCESSFUL AND THE SYSTEM ACHIEVED READY STATUS AT EACH POWER CYCLE. TRAVEL ON X, Y, AND Z AXES WAS AS EXPECTED. NO AUDIBLE NOISE WAS NOTED DURING OPERATION. NO PROBLEM FOUND. POWER SWITCHING BOARD HAS NOT BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA NEW ENGLAND DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 FDA-483 FEI: 3004785967. THIS REVIEW WAS PERFORMED AS A RESULT OF RECENT CHANGES/IMPROVEMENTS TO THE MEDTRONIC NAVIGATION, INC. MEDICAL DEVICE REPORT (MDR) REVIEW PROCESS AND IS FOR NON-ADVERSE EVENT REPORTABLE MALFUNCTIONS WITHIN THE LAST TWO YEARS WHERE THE REPORTED MALFUNCTION WAS NOT PREVIOUSLY ASSOCIATED WITH SERIOUS INJURIES. SIMILAR MALFUNCTIONS THAT HAD RESULTED IN SIGNIFICANT DELAYS OF SURGERY OR REQUIRED ADDITIONAL INTERVENTION HAD BEEN REPORTED AS MDR SERIOUS INJURIES. BASED ON THIS 483 OBSERVATION, THE REPORTING DETERMINATION HAS BEEN REVISED TO CONSIDER THESE MALFUNCTION EVENTS REPORTABLE. THIS PROCESS CHANGE RESULTED IN AN OVERALL INCREASE IN THE NUMBER OF MDRS FILED BY MEDTRONIC NAVIGATION, INC., SINCE APRIL 2016. IT SHOULD BE NOTED THAT THIS INCREASE IS NOT THE RESULT OF THE DISCOVERY OF NEW PRODUCT PROBLEMS, BUT RATHER THE RESULT OF A BROADER INTERPRETATION AND APPLICATION OF THE REGULATIONS WITHIN OUR PROCESSES.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT THE IMAGING SYSTEM HAD A MOTION BATTERY LOW WARNING, WHEN OPENING THE GANTRY AND MOVING OUT OF THE AXIS THE SYSTEM WAS NOT MOVING SMOOTHLY AND WAS MAKING AN UNEXPECTED NOISE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792761 O-ARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC. (LITTLETON) BI-700-00027-120

    Patients

    Seq Age Sex Outcome Treatment
    1