BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6075463 · Received November 3, 2016

    Report

    Report Number
    1723170-2016-03668
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    March 4, 2015
    Report Date
    November 3, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. THE REPRESENTATIVE WAS UNABLE TO REPLICATE THE REPORTED ISSUE. THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. THIS INITIATED A SOFTWARE INVESTIGATION TO DETERMINE THE ROOT CAUSE OF THE INFORMATION. THE SOFTWARE INVESTIGATION FOUND THAT THE THERE WAS INSUFFICIENT INFORMATION IN DETERMINING THE ROOT CAUSE OF THE ISSUE. LOG ANALYSIS SHOWED SEVERAL 3D SPIN ATTEMPTS, AND WITHOUT BEING ABLE TO REPLICATE THE ISSUE. THE SYSTEM IS FUNCTIONING AS DESIGNED. 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 (B)(4). 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 MEDTRONIC REPRESENTATIVE REPORTED THAT WHEN THE RADIOLOGIC TECHNOLOGIST (RT) AT THE SITE ATTEMPTED TO TAKE A 3D SPIN ON THE IMAGING SYSTEM, NOTHING OCCURRED. INITIAL TROUBLESHOOTING INCLUDED ENSURING THE RT HELD THE 3D SPIN BUTTON FOR A SUFFICIENT AMOUNT OF TIME, THEN ASSURING DOOR FUNCTIONALITY TO ENSURE IT IS NOT THE BATTERIES. THE REP WAS UNABLE TO REPLICATE THE REPORTED ISSUE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726219 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