BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6076635 · Received November 3, 2016

    Report

    Report Number
    1723170-2016-04078
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    August 24, 2015
    Report Date
    November 3, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE IMAGING SYSTEM EQUIPMENT. REPLACED MOBILE VIEW STATION (MVS) CENTRAL PROCESSING UNIT (CPU) BECAUSE OF INTERMITTENT TRACK PAD ISSUE. WHEN MEDTRONIC REPRESENTATIVE ARRIVED, TRACK PAD WAS WORKING. SEEMS TO OCCUR EVERY FEW WEEKS. THE KEYBOARD WAS REPLACED PREVIOUSLY. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. ISSUE RESOLVED WITH PART REPLACEMENT. THE MVS COMPUTER WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. INVESTIGATION FOUND THAT REPORTED PROBLEM WAS ATTRIBUTED TO KEYBOARD. MVS COMPUTER PRESENTED WITH LOST BIOS SETTINGS DUE TO LOW CMOS BATTERY. REPLACED CMOS BATTERY, THEN ATTEMPTED TO RESET BIOS SETTINGS UNABLE TO SUCCESSFULLY COMPLETE BIOS SETTINGS, BECAUSE EXPECTED BOOT OPTIONS 1 AND 2 WERE NOT AVAILABLE. RAID WAS INITIATED, AND IT WAS NOTED ONLY TWO HARD DRIVES ARE REPRESENTED, RATHER THAN THE EXPECTED FOUR. MVS COMPUTER WILL NOT BOOT TO WINDOWS. THE HARDWARE INVESTIGATION FOUND THAT THE FAILURE MODE WAS THE COMPUTER. FAILURE MECHANISM WAS C-MOS BATTERY VOLTAGE WAS LOW. (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 RADIOLOGIC TECHNOLOGIST (RT) FROM THE SITE REPORTED THAT THE MOUSE PAD ON THE KEYBOARD WAS NOT WORKING. THEY REBOOTED THE IMAGING SYSTEM AND FUNCTIONALITY WAS RESTORED. THIS OCCURRED AFTER A CASE, THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO FURTHER DETAILS REGARDING THIS ISSUE WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727671 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