BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6078837 · Received November 4, 2016

    Report

    Report Number
    1723170-2016-03264
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    April 2, 2014
    Report Date
    November 4, 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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 EQUIPMENT. THE IMAGING MODALITIES FAILED, IT WAS NOTED THAT MOBILE VIEW STATION (MVS) NOT BOOTING PROPERLY, BIOS NOT SET PROPERLY. THE MEDTRONIC REPRESENTATIVE ORDERED MVS CENTRAL PROCESSING UNIT (CPU) FOR REPLACEMENT. THE MEDTRONIC REPRESENTATIVE RETURNED TO THE SITE AND INSTALLED THE CPU, ADJUSTED WHEEL THAT WAS SQUEAKING AND TESTED IMAGE QUALITY. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. ISSUE RESOLVED WITH PART REPLACEMENT. THE COMPUTER MVS SERVER WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. INVESTIGATION CONFIRMED REPORTED PROBLEM "MVS NOT BOOTING PROPERLY. BIOS NOT SET PROPERLY'. 3V BATTERY DEPLETED LOSING BIOS SETTINGS. THE HARDWARE INVESTIGATION FOUND THAT REPORTED EVENT WAS RELATED TO AN ELECTRICAL FAILURE MODE. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(4) OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 FDA-483 FEI: (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 REPORTED TO A MEDTRONIC REPRESENTATIVE THAT UPON BOOTING, THE IMAGING SYSTEM GAVE A MESSAGE THAT THE BIOS SCREEN WAS REQUESTING THE USER TO PRESS AN F-KEY. THEY DID NOT KNOW WHICH KEY, BUT WHEN THEY PRESSED IT, IT BOOTED WITHOUT ISSUE. THE MEDTRONIC REPRESENTATIVE CONTACTED ANOTHER MEDTRONIC REPRESENTATIVE WHO IS SCHEDULED TO CHECK THE SYSTEM THE FOLLOWING DAY. 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
    730438 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