BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6095666 · Received November 11, 2016

    Report

    Report Number
    1723170-2016-04180
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    March 16, 2015
    Report Date
    November 11, 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 AFTER TAKING A STANDARD 3D SPIN THE IMAGE APPEARED HALF WHITE. THE SITE WAS UNABLE TO ACQUIRE CLEAR IMAGES AND HAD TO BRING IN A BACK UP IMAGING SYSTEM. THERE WAS NO PATIENT IMPACT REPORTED AND THE DELAY IN SURGERY WAS LESS THAN AN HOUR. SURGERY PROCEEDED AS PLANNED. IT WAS REQUESTED THAT THE SYSTEM'S LOGS/IMAGES BE SENT TO THE MANUFACTURER FOR FURTHER ANALYSIS. THE IMAGES THAT WERE SENT BACK TO THE MANUFACTURER WERE INSUFFICIENT FOR FURTHER ANALYSIS. THE SITE HAD DELETED ANY PERTINENT DATA, SO THE SOFTWARE INVESTIGATION WAS UNABLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. 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 MEDTRONIC REPRESENTATIVE REPORTED THAT AFTER TAKING A STANDARD 3D SPIN THE IMAGE APPEARED HALF WHITE. THE SITE WAS UNABLE TO ACQUIRE CLEAR IMAGES AND HAD TO BRING IN A BACK UP IMAGING SYSTEM. THERE WAS NO PATIENT IMPACT REPORTED AND THE DELAY IN SURGERY WAS LESS THAN AN HOUR. SURGERY PROCEEDED AS PLANNED. AN ONSITE INSPECTION WAS SCHEDULED FOR A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746756 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 8 YR