BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6058127 · Received October 26, 2016

    Report

    Report Number
    1723170-2016-03318
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    August 26, 2015
    Report Date
    October 26, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. FIELD SYSTEM ENGINEER WAS INFORMED BY THE SITE ABOUT A GREEN SPLASH SCREEN ON THE MVS WITH AN ERROR MESSAGE "COULD NOT LOAD CONFIG FILE TO IAS" AND THE SYSTEM WOULDN'T FULLY BOOT. UPON FURTHER ONSITE INVESTIGATION, THE ENGINEER DISCOVERED THAT THE MOBILE VIEW STATION'S CONFIGURATION FILES WERE CORRUPTED, THE ENGINEER ALSO DISCOVERED THAT THE ETHERNET PORT KIT ALONG WITH THE ETHERNET CABLE WERE DAMAGED. FIELD SYSTEM ENGINEER WAS ABLE TO RESOLVE THE ISSUE BY RE-LOADING THE CONFIGURATION FILES AND REPLACING THE ETHERNET PORT KIT. NO FURTHER ISSUES WERE REPORTED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. SYSTEM PASSED ALL TESTS DURING SYSTEM CHECKOUT AND NO FURTHER ACTION IS REQUIRED AT THIS TIME. 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 (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 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

    THE FIELD SERVICE ENGINEER RECEIVED A REPORT FROM THE SITE REGARDING A GREEN SPLASH SCREEN ON THE MOBILE VIEWING STATION WITH AN ERROR MESSAGE "COULD NOT LOAD CONFIG FILE TO IAS" AND THE SYSTEM WOULDN'T FULLY BOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708246 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