BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6064526 · Received October 28, 2016

    Report

    Report Number
    1723170-2016-03221
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    December 28, 2015
    Report Date
    October 28, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SITE'S BIOMEDICAL ENGINEER REPORTED THAT THE IMAGING SYSTEM WAS NOT EXPOSING. INITIALLY THE RADIOLOGIST WAS ABLE TO TAKE 2D LOCALIZER IMAGES, THEN WENT TO TAKE A 3D SPIN AND THE IMAGING SYSTEM APPEARED TO BE TAKING THE SPIN BUT THE 3D IMAGE CAME ACROSS BLACK. REBOOTED THE IMAGING SYSTEM TWICE. AFTER THE REBOOTS THEY WERE NOT ABLE TO TAKE 2D OR 3D IMAGES. SITE CONTINUED SURGERY WITH THE ANOTHER IMAGING SYSTEM ON-SITE. DELAY WAS LESS THAN AN HOUR AND THERE WAS NO IMPACT ON PATIENT OUTCOME. UPON RETURNED PRODUCT ANALYSIS, IT WAS DISCOVERED THAT THE ISSUE WAS CAUSED BY A FAULTY INTERFACE CONTROL BOARD. BOARD REPLACE AND ISSUE WAS RESOLVED. NO OTHER ISSUES WERE REPORTED. A FULL IMAGING SYSTEM CHECK-OUT WAS COMPLETED AND ALL TESTS PASSED. FULL SYSTEM FUNCTIONALITY WAS CONFIRMED AND THE SYSTEM WAS RETURNED TO SERVICE. (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

    SITE'S BIOMEDICAL ENGINEER REPORTED THAT THE IMAGING SYSTEM WAS NOT EXPOSING. INITIALLY, THE RADIOLOGIST WAS ABLE TO TAKE 2D LOCALIZER IMAGES, WENT TO TAKE A 3D SPIN, IMAGING SYSTEM APPEARED TO BE TAKING THE SPIN BUT THE 3D IMAGE CAME ACROSS BLACK. REBOOTED THE IMAGING SYSTEM TWICE. AFTER THE REBOOTS THEY WERE NOT ABLE TO TAKE 2D OR 3D IMAGES. SITE CONTINUED SURGERY WITH THE OTHER ARM AT THE SITE. DELAY WAS LESS THAN AN HOUR AND THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714951 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