BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5845258 · Received August 3, 2016

    Report

    Report Number
    1723170-2016-01683
    Event Type
    Malfunction
    Date Received
    August 3, 2016
    Date of Event
    October 16, 2015
    Report Date
    August 3, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE VISITED THE SITE TO EXAMINE THE MEDTRONIC IMAGING SYSTEM, RESULTING IN THE DECISION TO REPLACE THE COMPUTER, POWER BOARD AND THE MVS CABLE ASSEMBLY. AFTER REPLACING THE PARTS, THE REPRESENTATIVE PERFORMED AN IMAGING SYSTEM CHECK-OUT AND TESTED AREAS PASSED. SYSTEM PERFORMED AS INTENDED. TESTING OF THE RETURNED PARTS REVEALED THAT THE COMPUTER'S C-MOS BATTERY VOLTAGE WAS LOW, DIRECTLY CONTRIBUTING TO THE REPORTED EVENT. (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 USE OF THE O-ARM IMAGING SYSTEM WAS ABORTED. 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 WHILE IN A SPINAL FUSION PROCEDURE REPORTED THAT THE MEDTRONIC IMAGING SYSTEM WAS NOT BOOTING UP. MULTIPLE (FOUR) REBOOTS FAILED TO RESOLVE THE ISSUE. MEDTRONIC IMAGING AND NAVIGATION WAS ABORTED. NO DELAY TO SURGERY OR CLINICAL IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495440 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 78 YR