BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6095561 · Received November 11, 2016

    Report

    Report Number
    1723170-2016-03269
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    August 14, 2014
    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

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. A FAILED SHORTED FILAMENT BOARD CAUSED SECONDARY COMPONENT FAILURES, UNDER SUSPICION, THE STANDALONE, ATP CONSOLE, AND HT CONTROLLER WAS REPLACED AND CONFIGURED INTO THE IMAGING GENERATOR. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. ISSUE RESOLVED WITH PART REPLACEMENT. PARTS WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. INVESTIGATION OF THE STANDALONE X RELAY CONFIRMED REPORTED PROBLEM "GENERATOR WILL NOT BOOT". STAND ALONE BOARD PASSED BENCH LEVEL TEST. STAND ALONE BOARD WAS INSTALLED ON THE IMAGING SYSTEM, INITIALLY GENERATOR BOOTED OK, FEW MINUTES AFTER POWER UP, THE GENERATOR WENT TO NOT READY STATE ON THE IMAGING SYSTEM APPLICATION. ERROR 1 WAS DISPLAYED. IT WAS FOUND TO HAVE AN ELECTRICAL FAILURE; ERROR 1 FAILURE MECHANISM. THE HARDWARE INVESTIGATION OF THE PCB FILAMENT DRIVER BOARD CONFIRMED REPORTED PROBLEM "FAILED FILAMENT DRIVER BOARD". BOARD HAD BURNT CAPACITOR C9. DEFECTIVE FILAMENT DRIVER BOARD. IT WAS FOUND TO HAVE AN ELECTRICAL FAILURE; BURNT CAPACITOR FAILURE MECHANISM. THE HARDWARE INVESTIGATION OF THE ATP CONSOLE COULD NOT CONFIRM REPORTED PROBLEM. ATP BOARD WAS INSTALLED IN THE IMAGING SYSTEM AND RAN WITHOUT ANY ISSUES. REPORTED PROBLEM WAS DUE DEFECTIVE FILAMENT DRIVER BOARD RECEIVED ALONG WITH THE ATP BOARD. NO FAULT FOUND. THE FUSE AND RECTIFIER PARTS HAVE NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA NEW ENGLAND DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 FDA-483 FEI: 3004785967. 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 BIOMED GOT AN ALL BLACK 3D IMAGE ON THE IMAGING SYSTEM. WHEN THEY REBOOTED THE SYSTEM THEY HEARD A LOUD POP NOISE FROM THE GENERATOR AND A BEEP, AFTER THAT THE SYSTEM STAYED IN THE INITIALIZING STATE AND DID NOT FULLY BOOT. 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
    746698 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