BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 6138835 · Received December 1, 2016

    Report

    Report Number
    1723170-2016-05407
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    February 23, 2016
    Report Date
    December 1, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OWB
    PMA / PMN Number
    K151000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 FOUND THAT THE IMAGING SYSTEM WOULD NOT START UP COMPLETELY WHERE THE SYSTEM WOULD BEEP. PRELIMINARY LOG ANALYSIS FOUND THAT AN ERROR MESSAGE APPEARED. THE GFI MODULE WAS THEN REPLACED. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE GFI MODULE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. TESTING FOUND THAT WHEN TESTING, THE CURRENT WOULD DRIFT. THIS CONFIRMED AN ELECTRICAL FAILURE. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(6) DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 (B)(6). 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, WHILE OUTSIDE OF A PROCEDURE, THE IMAGING SYSTEM WOULD NOT START UP PROPERLY. WHERE THE "INITIALIZING PLEASE WAIT" PROMPT APPEARED AND WOULD NOT CLOSE. THE SYSTEM WAS RESTARTED WHICH DID NOT RESOLVE THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790265 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC. (LITTLETON)

    Patients

    Seq Age Sex Outcome Treatment
    1