BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6101104 · Received November 14, 2016

    Report

    Report Number
    1723170-2016-04514
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    August 26, 2014
    Report Date
    November 14, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. A MEDTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO SITE TO TROUBLESHOOT ISSUE. CHECKED SYSTEM LOGS FOR EARLY 3D TERMINATION AND TESTED 3D IMAGING, A FAULTY ETHERNET CABLE WAS FOUND RELATED TO THE NAVIGATION UNIT ASKED CUSTOMER TO REPLACE. ALSO FOUND INTERMITTENT GENERATOR OVERLOAD ERRORS. THE 3D SPIN WOULD NOT COMPLETE. A REPLACEMENT XRAY TUBE WAS SENT TO SITE. THE FSE REPLACED THE TUBE AND TESTED SYSTEM, IT PASSED ALL CHECKS AND RETURNED TO USE. THE XRAY TUBE WAS SENT BACK TO MANUFACTURER FOR EVALUATION. COULD NOT CONFIRM REPORTED PROBLEM, THE TUBE WAS INSTALLED IN A WORKING IMAGING SYSTEM AND RAN WITHOUT ANY ISSUES FOR 8 DAYS. NO FURTHER ISSUES REPORTED. (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 SITE REPRESENTATIVE REPORTED AN 'EARLY TERMINATION ERROR' WAS DISPLAYED ON THE MOBILE VIEW STATION (MVS) DURING THEIR INITIAL 3D SPIN. THERE WAS ALSO A LOUD CRACKING SOUND FROM THE GENERATOR. ANOTHER SPIN WAS IMMEDIATELY ACQUIRED; SPIN WAS COMPLETED BUT NO IMAGES WERE DISPLAYED ON THE MVS. AT THE END OF THE PROCEDURE A FINAL CONFORMATION SPIN WAS ACQUIRED SUCCESSFULLY AND IMAGES COULD BE VIEWED NORMALLY. SYSTEM WAS NOT REBOOTED DURING THE CASE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750387 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