BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6145996 · Received December 5, 2016

    Report

    Report Number
    1723170-2016-05691
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Date of Event
    November 8, 2016
    Report Date
    June 21, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATP CONSOLE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. INSTALLED ATP CONSOLE IN IMAGING SYSTEM. START UP, GENERATOR READY AND BOTH 2D AND 3D IMAGING ARE SUCCESSFUL. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL.

    Additional Manufacturer Narrative · 1

    (B)(6). EVENT PROBLEM AND EVALUATION: ON 15-NOV-2016, A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. AN ISSUE WAS FOUND WITH THE ANATOMICAL PROFILE (ATP) BOARD. AFTER REPLACING THE ATP BOARD, A SYSTEM CHECK-OUT WAS PERFORMED. THE MECHANICAL TEST, IMAGING TEST AND SAFETY INSPECTION ALL PASSED; SYSTEM PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT DURING PRE-OP SETUP FOR A SPINAL FUSION PROCEDURE, THEY WERE UNABLE TO TAKE 2D FLUORO IMAGES; THE IMAGING SYSTEM WAS NOT RESPONDING WHEN THE BUTTON WAS PRESSED. BOTH THE HAND-SWITCH AND FOOT-SWITCH WERE TRIED, BUT THIS DID NOT RESOLVE THE ISSUE. FURTHER TROUBLESHOOTING INVOLVED RE-BOOTING THE SYSTEM WITH THE UMBILICAL CABLE CONNECTED, AND DISCONNECTED, BUT THE SYSTEM REMAINED UNRESPONSIVE IN ¿INITIALIZING, PLEASE WAIT¿ STATUS. THE X-RAY WOULD NOT INITIALIZE, AND THE REMOTE DESKTOP SHOWED THE GENERATOR WAS ¿NOT READY.¿ THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE IMAGING SYSTEM (AND NAVIGATION). A STANDARD 2D C-ARM WAS USED INSTEAD. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF 20-30 MINUTES DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795624 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