BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6076633 · Received November 3, 2016

    Report

    Report Number
    1723170-2016-04746
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    February 18, 2015
    Report Date
    November 3, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER FIELD NOT SUFFICIENT TO HOLD ALL DIGITS, SHOULD READ: (B)(6). A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINAL FUSION PROCEDURE, THE IMAGE ACQUISITION SYSTEM (IAS) WAS UNRESPONSIVE IN 'SYSTEM BOOTING PLEASE WAIT'. THEY REBOOTED THE SYSTEM 4-5 TIMES AND THE SYSTEM WAS ABLE TO ESTABLISH COMMUNICATION SUCCESSFULLY AND THEY WERE ABLE TO TAKE IMAGES. NO DELAY TO THE SURGERY, ISSUE OCCURRED PRIOR TO WHEN THE SURGEON NEEDED THE IMAGING SYSTEM. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME. ONSITE INVESTIGATION TOOK PLACE TO FURTHER LOOK INTO THIS ISSUE BUT THE FIELD REP WAS UNABLE TO REPRODUCE THE PROBLEM OR PINPOINT ANY SUSPECT PARTS TO SEND BACK TO MANUFACTURER. FIELD REP WILL CONTINUE TO MONITOR THE SYSTEM. A FULL IMAGING SYSTEM CHECK-OUT WAS COMPLETED 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

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINAL FUSION PROCEDURE, THE IMAGE ACQUISITION SYSTEM (IAS) WAS UNRESPONSIVE IN 'SYSTEM BOOTING PLEASE WAIT'. THEY REBOOTED THE SYSTEM 4-5 TIMES AND THE SYSTEM WAS ABLE TO ESTABLISH COMMUNICATION SUCCESSFULLY AND THEY WERE ABLE TO TAKE IMAGES. NO DELAY TO THE SURGERY, ISSUE OCCURRED PRIOR TO WHEN THE SURGEON NEEDED THE IMAGING SYSTEM. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726971 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 76 YR