BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5845289 · Received August 3, 2016

    Report

    Report Number
    1723170-2016-01685
    Event Type
    Malfunction
    Date Received
    August 3, 2016
    Date of Event
    August 11, 2014
    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
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE VISITED THE SITE TO EXAMINE THE MEDTRONIC IMAGING SYSTEM, RESULTING IN THE DECISION TO REPLACE THE MVS CABLE INTERFACE. AFTER REPLACING THE PARTS, THE REPRESENTATIVE PERFORMED AN IMAGING SYSTEM CHECK-OUT AND TESTED AREAS PASSED. SYSTEM PERFORMED AS INTENDED. INVESTIGATION OF THE RETURNED PART CONFIRMED AN ELECTRICAL FAILURE FOR THE CABLE (BROKEN CABLE WIRES). (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 HOSPITAL REPRESENTATIVE REPORTED THAT WHILE IN A SPINAL FUSION PROCEDURE, THE MEDTRONIC IMAGING SYSTEM WAS SHOWING AS CONNECTED, NOT READY. THE SITE TRIED RESEATING THE UMBILICAL AND REBOOTED THE SYSTEM, NO CHANGE; ALSO ATTEMPTED TO RESTART THE MVS APPLICATION, NO CHANGE. MOTION AND GENERATOR HAD GREEN CHECKS. MVS WAS BOOTED UP TO THE PATIENT INFO SCREEN. MEDTRONIC NAVIGATION SYSTEM SHOWED NETWORK CABLE DISCONNECTED TO MVS. MEDTRONIC IMAGING WAS ABORTED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495513 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