BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6070608 · Received November 1, 2016

    Report

    Report Number
    1723170-2016-04709
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    July 16, 2014
    Report Date
    November 1, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER FIELD NOT SUFFICIENT TO HOLD ALL DIGITS, SHOULD READ: (B)(6). SITE REPORTED THAT, IN PREPARATION FOR A SPINAL FUSION PROCEDURE, THERE WAS NO LINE POWER LIGHT ON THE MOBILE VIEW STATION (MVS) AND WHEN THEY TURNED THE SYSTEM ON, IT WAS BEEPING. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME. OVER-THE-PHONE TROUBLESHOOTING OF THE ISSUE WAS PROVIDED, THEY TRIED SWITCHING TO ANOTHER WALL PLUG, NO CHANGE. TRIED REBOOTING THE MVS, BUT IT WOULD NOT POWER BACK ON AT ALL. SINCE PATIENT WAS ON THE TABLE, THE SITE EMPLOYEE WAS WALKED THROUGH SAFELY REPLACING THE F11 AND F12 FUSES ON THE MVS BOARD. ONCE FUSES WERE REPLACED AND RECONNECTED TO WALL POWER, THEY HAD A LINE POWER LIGHT AND WERE ABLE TO USE IMAGING SYSTEM FOR THE CASE. ISSUE RESOLVED AND NO FURTHER ISSUES WERE REPORTED. A FULL IMAGING SYSTEM CHECK-OUT WAS LATER COMPLETED BY A FIELD REP AND ALL TESTS PASSED. FULL SYSTEM FUNCTIONALITY WAS CONFIRMED AND THE SYSTEM WAS RETURNED TO SERVICE. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(4) DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 FDA-483 FEI: 3004785967. 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

    SITE REPORTED THAT, IN PREPARATION FOR A SPINAL FUSION PROCEDURE, THERE WAS NO LINE POWER LIGHT ON THE MOBILE VIEW STATION (MVS) AND WHEN THEY TURNED THE SYSTEM ON, IT WAS BEEPING. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720000 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 44 YR