BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6079358 · Received November 4, 2016

    Report

    Report Number
    1723170-2016-04602
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    July 29, 2015
    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
    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 FIELD SERVICE ENGINEER (FSE) WENT TO SITE TO TROUBLESHOOT ISSUE. IT WAS FOUND, THAT AN INTERMITTENT BIOS PROBLEMS PREVENTED THE IMAGE ACQUISITION SYSTEM (IAS) COMPUTER FROM STARTING. REPLACEMENT COMPUTER WAS SENT TO SITE. REPLACED COMPUTER, UPDATED AND INSTALLED 3.1.6 ON MOBILE VIEW STATION (MVS) COMPUTER TO MATCH, RECONFIGURED THE SYSTEM, AND TESTED THE SYSTEM WITH THE NAVIGATION SYSTEM. RESTARTED THE SYSTEM MANY TIMES WITHOUT PROBLEMS. ATTACHED ERROR LOG TO THE CASE FOR REVIEW. SYSTEM TESTED AND PASSED ALL CHECKS, PUT BACK INTO USE. COMPUTER WAS SENT BACK TO THE MANUFACTURER FOR EVALUATION. CONFIRMED "WILL NOT BOOT INTERMITTENTLY,GREEN LIGHT SOLID, BUT NO AMBER." IAS COMPUTER EXPERIENCES INTERMITTENT BOOT UP ISSUES DUE TO LOW CMOS BATTERY. BATTERY MEASURED 3.0VDC. AT TIMES THE COMPUTER WILL BOOT COMPLETELY. OTHER TIMES, IT WILL SUCCESSFULLY BOOT TO WINDOWS, HOWEVER THE IMAGING SYSTEM APPLICATION WILL NOT SUCCESSFULLY BOOT. STILL OTHER TIMES, BLANK SCREEN AND NO HDD ACTIVITY. RESET THE DATE IN THE BIOS SETTINGS, AND AT POWER CYCLE IT WAS LOST. NO FURTHER ISSUES REPORTED. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE (B)(6) DISTRICT OFFICE ON (B)(6) 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 (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 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 CALLED TO REPORT THE SYSTEM IS HAVING INTERMITTENT BOOT ISSUES WHERE IT WILL REMAIN IN "SYSTEM BOOTING PLEASE WAIT," FOR APPROXIMATELY 30 MINUTES BEFORE IT WILL REQUIRE A REBOOT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729243 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