BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 6606478 · Received June 1, 2017

    Report

    Report Number
    1723170-2017-02302
    Event Type
    Malfunction
    Date Received
    June 1, 2017
    Date of Event
    May 5, 2017
    Report Date
    June 15, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OWB
    PMA / PMN Number
    K151000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. AFTER REVIEWING THE LOGS FROM THE IMAGING SYSTEM, IT SHOWED AS "MOTOR POWER (96 V) IS OFF". THE REP REPLACED THE POWER ENCLOSURE BOARD WHICH RESOLVED THE ISSUE. THE REP REBOOTED THE IMAGE ACQUISITION SYSTEM (IAS) 10 TIMES WITHOUT ANY ISSUE. THE REP COMPLETED A FULL SYSTEM CHECKOUT. ALL TESTS PASSED SUCCESSFULLY, AND THE SYSTEM IS FULLY FUNCTIONAL AND READY FOR CLINICAL USE.

    Additional Manufacturer Narrative · 1

    THE LOG INVESTIGATION SUSPECTED A HARDWARE FAILURE. THE SOFTWARE INVESTIGATION FOUND THAT ALL INCIDENTS OF 'ERROR INITIALIZING COLLIMATOR' WERE DUE TO "MOTION CONTROL ERROR, MSG: 622 (622.847), TC:22, CTRL: ROTOR". THIS ERROR INDICATES THAT SOURCE HOMING FAILED DUE TO LIMIT SWITCH; LIMIT SWITCH WAS ACTIVE WHICH PREVENTED A MOVEMENT ON SOURCE AXIS DURING HOMING. IT HAS BEEN RECOMMENDED VERIFYING CONNECTIVITY FOR LIMIT SWITCHES FOR SOURCE; ALSO VISUALLY INSPECT SOURCE LIMIT SWITCHES FOR ANY DAMAGE. THE POWER ENCLOSURE BOARD WAS RETURNED FOR ANALYSIS. NO FINDINGS AVAILABLE AS THE PART IS STILL UNDER ANALYSIS.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. ONSITE INVESTIGATION WAS PREFORMED AND THE FIELD REPRESENTATIVE WAS UNABLE TO REPLICATE THE REPORTED EVENT. IT WAS NOT REPORTED THAT PARTS WERE REPLACED OR RETURNED.

    Additional Manufacturer Narrative · 1

    THE POWER CONVERSION ENCLOSURE FOR THE IMAGING SYSTEM WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE ENCLOSURE WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE IMAGING SYSTEM DISPLAYED THE ERROR MESSAGE 'ERROR INITIALIZING COLLIMATOR'. REBOOTING THE SYSTEM DID NOT RESOLVED THE ISSUE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387517 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC. (LITTLETON)

    Patients

    Seq Age Sex Outcome Treatment
    1