BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6141096 · Received December 2, 2016

    Report

    Report Number
    1723170-2016-03890
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    September 18, 2015
    Report Date
    December 2, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. COULD NOT REPLICATE ISSUE. REPETITIVE REMOVAL AND APPLICATION OF AC WILLPOWER WITH NO ISSUES OBSERVED. REPLENISHED MOBILE VIEW STATION (MVS) POWER BOARD FUSES TO SYSTEM STOCK AS SUPPLIED WITH NEW MACHINE. RETURNED TO SITE AND REPLACED THE MVS UNINTERRUPTIBLE POWER SUPPLY (UPS) TO ELIMINATE POSSIBILITY OF UPS CREATING TRANSIENT SPIKES CAUSING MVS POWER BOARD FUSE FAILURES. THE IMAGING SYSTEM PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE FUSES HAVE NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. THE UPS POWER SUPPLY WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. CONFIRMED REPORTED PROBLEM OF IMAGING SYSTEM, IS NOT CHARGING, THE UPS FAILED 5 MINUTE LOAD TEST IN 3 MINUTES. UPS PASSED 5 MINUTE LOAD AFTER INSTALLING KNOWN GOOD BATTERIES. DIAGNOSED PROBLEM: BATTERIES BAD, NOT HOLDING A FULL CHARGE. ELECTRICAL FAILURE MODE. 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 (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

    DISPATCH FOR THE SITE REPORTED THAT BETWEEN PROCEDURES, THE SITE NOTICED THAT THEIR IMAGING SYSTEM WAS NOT CHARGING WHEN PLUGGED INTO THE WALL. NO PATIENT WAS PRESENT WHEN THIS ISSUE WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791326 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