BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6072727 · Received November 2, 2016

    Report

    Report Number
    1723170-2016-03657
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    September 22, 2015
    Report Date
    November 2, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. IT WAS REPORTED BY A MEDTRONIC REPRESENTATIVE THAT THE IMAGING SYSTEM RESOLUTION WAS CONFIRMED WORKING ALONGSIDE AN AUTHORIZED BIOMEDICAL ENGINEER. UPON COMPLETION OF THE DATABASE TROUBLESHOOTING. AN ISSUE OCCURRED WITH THE UNINTERRUPTIBLE POWER SUPPLY (UPS) OF THE IMAGING SYSTEM. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. A REPLACEMENT UNINTERRUPTIBLE POWER SUPPLY (UPS) WAS SENT TO THE SITE ON 22 SEPTEMBER 2015. THE POWER SUPPLY WAS THEN REPLACED AND THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. FOLLOWING THIS AN INVESTIGATION INTO THE UNINTERRUPTIBLE POWER SUPPLY (UPS) AS WELL AS A SOFTWARE INVESTIGATION WERE INITIATED TO DETERMINE THE ROOT CAUSE OF BOTH ANOMALIES THAT OCCURRED. THE SOFTWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS UNRELATED TO A SOFTWARE ISSUE. THE SOFTWARE FUNCTIONED AS DESIGNED. THE POWER SUPPLY WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE TESTING FOUND THAT THE UNINTERRUPTIBLE POWER SUPPLY (UPS) WAS UNABLE TO CHARGE THE BATTERIES INSIDE OF THE UNIT. THIS INDICATES AN ELECTRICAL FAILURE THROUGH THE BATTERIES NOT HOLDING CHARGE. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(4) 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, WHILE IN A SPINAL FUSION, DURING THE START UP OF THE IMAGING SYSTEM. THE SYSTEM STATED AN ERROR MESSAGE THAT INDICATED THERE WAS POSSIBLE DAMAGE TO THE SYSTEM DATABASE. INITIAL TROUBLESHOOTING WAS PERFORMED BY RESTARTING THE SYSTEM TWICE, WITH NEITHER OCCURRENCE RESOLVING THE ISSUE. A PATIENT WAS PRESENT IN THE ROOM. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724905 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