BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6083063 · Received November 7, 2016

    Report

    Report Number
    1723170-2016-03268
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    February 12, 2015
    Report Date
    November 7, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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. CHECKED AND ADJUSTED LOUVER COVER WAS BENT OUT OF SHAPE AND IT WAS RUBBING WITH GANTRY DOOR WHICH PREVENTED THE GANTRY DOOR FROM CLOSING COMPLETELY. TESTED GANTRY DOOR OPEN AND CLOSE MANY TIMES. A MEDTRONIC REPRESENTATIVE CAME BACK TO REPLACE THE COVER AND TEST THE EQUIPMENT. THE IMAGING SYSTEM FAILED THE MECHANICAL TEST. DOOR NOT CLOSING. FOUND THE LOWER LOUVER COVER TO BE BENT AND STOPPING THE DOOR FROM CLOSING. THE MEDTRONIC REPRESENTATIVE REPLACED LOWER LOUVER COVER. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. ISSUE RESOLVED WITH PART REPLACEMENT. THE LOUVER COVER WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. INVESTIGATION CONFIRMED COMPLAINT "LOUVER COVER IS DAMAGED." COVER IS BENT, AND COVER EXHIBITS MANY DEEP GOUGES INTO THE METAL. THE HARDWARE INVESTIGATION FOUND THAT REPORTED EVENT WAS RELATED TO THE PHYSICAL DAMAGE FAILURE MECHANISM. IT WAS FOUND TO BE DENTED, NICKED, SCRATCHED, AND BENT. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(4) OFFICE ON (B)(6) 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO (B)(6) 2016 (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 (B)(4) 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 (B)(6) 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 THE LOUVER COVER FOR THE IMAGING SYSTEM IS DAMAGED AND NEEDS TO BE REPLACED IN ORDER FOR THE DOOR TO CLOSE PROPERLY. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733583 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