BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6081287 · Received November 7, 2016

    Report

    Report Number
    1723170-2016-04128
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    January 19, 2016
    Report Date
    February 6, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. A SITE REPRESENTATIVE REPORTED THAT DURING A CASE 2D IMAGES WERE TAKEN, AND BLACK AND WHITE LINES WERE OBSERVED ON THE IMAGES WHICH RESULTED IN THE SITE BEING UNABLE TO SEE THE ANATOMY. 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. DURING THE ONSITE INSPECTION, THE REPORTED ISSUE WAS CONFIRMED. USERS WOULD GET BLACK AND WHITE HORIZONTAL LINES WHEN SHOOTING 2D SHOTS. THIS WAS INTERMITTENT AND THEY WOULD BE ABLE TO REBOOT AND IT WOULD GO AWAY. IT WAS DETERMINED THAT THIS WOULD BE CAUSED BY THE PAXSCAN. THE MEDTRONIC REPRESENTATIVE REPLACED THE PAXSCAN COMPUTER. A SUCCESSFUL SYSTEM CHECKOUT WAS PERFORMED WHICH VERIFIED THAT THE ISSUE HAD BEEN RESOLVED. THE REPLACED COMPUTER WAS SENT TO THE MANUFACTURE FOR PART ANALYSIS. DURING PART ANALYSIS, THERE WAS A CONFIRMED ELECTRICAL FAILURE ON THE COMPUTER. 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.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT DURING A CASE 2D IMAGES WERE TAKEN, AND BLACK AND WHITE LINES WERE OBSERVED ON THE IMAGES WHICH RESULTED IN THE SITE BEING UNABLE TO SEE THE ANATOMY. 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
    732573 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