BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6100615 · Received November 14, 2016

    Report

    Report Number
    1723170-2016-03335
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 26, 2015
    Report Date
    November 14, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 SYSTEM. A REPLACEMENT MOBILE VIEW STATION (MVS) COMPUTER WAS SHIPPED TO THE SITE. AFTER REPLACING MVS COMPUTER, THE MEDTRONIC REPRESENTATIVE PERFORMED AN IMAGING SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. AN INVESTIGATION WAS COMPLETED AT THE MEDTRONIC FACILITY WHICH CONFIRMED THE REPORTED EVENT WAS CAUSED BY A SOFTWARE ANOMALY. A BENCH TEST OF BIOS SETTINGS AND TIME/DATE VERIFICATION, AS WELL AS A VIRUS SCAN, WERE SUCCESSFUL. THE MOBILE VIEW STATION (MVS) COMPUTER WAS INSTALLED IN THE IMAGE ACQUISITION SYSTEM (IAS) 267. AT BOOT-UP, THE IMAGE ACQUISITION SYSTEM (IAS) APPLICATION ANNOUNCED "DAMAGED DATABASE ERROR DUE TO CORRUPTED FILE WITHIN IMAGE ACQUISITION SYSTEM (IAS) SOFTWARE.". THE ISSUE WAS NOT DUE TO A DAMAGED SECTION ON THE HARD DRIVE. RAID WAS SUCCESSFUL WITH NO CORRUPTED SECTIONS OF ANY HARD DRIVES. THE MVS SOFTWARE WAS REINSTALLED AND THE ISSUE WAS RESOLVED. PATIENT DATA REMOVAL WAS PERFORMED. THE MVS COMPUTER FUNCTIONS AS EXPECTED. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(6) DISTRICT OFFICE ON APRIL 7, 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, FOLLOWING UP WITH THE SITE, REPORTED THAT THE IMAGE ACQUISITION SYSTEM (IAS) COULD NOT TAKE 3D IMAGES NOR STORE THEM. AN ERROR MESSAGE DISPLAYED: "AN ERROR HAS OCCURRED THAT MAY HAVE DAMAGED THE SYSTEM'S DATABASE. PLEASE RESTART THE IMAGE ACQUISITION SYSTEM (IAS) AND MOBILE VIEW STATION (MVS). IF THIS MESSAGE APPEARS AGAIN, PLEASE CONTACT MEDTRONIC TECHNICAL SERVICE FOR ASSISTANCE." THE SAME ISSUE WAS VALID WHEN STORING MULTIPLE 2D SCANS IN A ROW. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752242 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