BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6062239 · Received October 27, 2016

    Report

    Report Number
    1723170-2016-03285
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Date of Event
    May 12, 2015
    Report Date
    October 27, 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

    A MEDTRONIC REPRESENTATIVE REPORTED THAT AN ERROR MESSAGE STATING "SYSTEM STANDBY FAILED" SHOWED ON THE SCREEN AFTER TWO SPINS ON THE IMAGING SYSTEM. IT WAS NOTED THAT THE MOBILE VIEW STATION (MVS) HAD BEEN UNPLUGGED FOR A LONG PERIOD OF TIME PRIOR TO IMPLEMENTING THE SPINS. IT WAS ALSO REPORTED THAT THE ISSUE WAS NOTICED AFTER THE IMAGING SYSTEM HAD BEEN USED IN A CASE. NO PATIENT WAS PRESENT. THE IMAGING SYSTEM LOGS WERE REQUESTED FOR ANALYSIS AT THIS TIME AND A FUTURE ONSITE INVESTIGATION WAS SCHEDULED. WHEN THE INVESTIGATION TOOK PLACE, THE MEDTRONIC REPRESENTATIVE WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. A SUCCESSFUL SYSTEM CHECKOUT WAS PERFORMED, WHICH VERIFIED THAT THERE WERE NO ISSUES CURRENTLY PRESENT. THE LOGS WERE ANALYZED IN A SOFTWARE INVESTIGATION WHERE IT WAS FOUND THAT THIS ISSUE WAS A SOFTWARE ANOMALY THAT IS BEING TRACKED. REFERENCES TO THIS CASE HAVE BEEN ADDED TO THAT RECORD. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE (B)(6) DISTRICT 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 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 AN ERROR MESSAGE STATING "SYSTEM STANDBY FAILED" SHOWED ON THE SCREEN AFTER TWO SPINS ON THE IMAGING SYSTEM. IT WAS NOTED THAT THE MOBILE VIEW STATION (MVS) HAD BEEN UNPLUGGED FOR A LONG PERIOD OF TIME PRIOR TO IMPLEMENTING THE SPINS. IT WAS ALSO REPORTED THAT THE ISSUE WAS NOTICED AFTER THE IMAGING SYSTEM HAD BEEN USED IN A CASE. NO PATIENT WAS PRESENT. THE IMAGING SYSTEM LOGS WERE REQUESTED FOR ANALYSIS AT THIS TIME AND A FUTURE ONSITE INVESTIGATION WAS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711897 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