BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6084538 · Received November 7, 2016

    Report

    Report Number
    1723170-2016-03503
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    May 13, 2014
    Report Date
    November 7, 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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT PROBLEM AND EVALUATION: ON 28-MAY-2014, A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT AND FOUND ISSUES WITH DROPPING DOOR COUNTS AND TILT ERROR MESSAGES. THE GANTRY CONTROLLER AND IMAGE ACQUISITION SYSTEM (IAS) CENTRAL PROCESSING UNIT (CPU) WERE REPLACED TO RESOLVE THE ISSUE WITH DOOR COUNTS AND INTERMITTENT LOSS OF CONFIGURATION. NO IMAGE QUALITY ISSUES WERE FOUND. THE IMAGING SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. THE IMAGING SYSTEM COMPUTER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION, AND A SOFTWARE FAILURE MODE WAS IDENTIFIED DURING TESTING. A ¿CORRUPT FILE¿ ERROR APPEARED DURING TESTING DUE TO A CORRUPT OPERATING SYSTEM. THE FOLLOWING PARTS WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS; HOWEVER, THESE PARTS DID NOT CAUSE THE REPORTED EVENT AND/OR NO FUNCTIONAL PROBLEM WAS FOUND. THE GANTRY MOTION CONTROL BOX WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS, BUT NO FUNCTIONAL PROBLEM WAS FOUND DURING TESTING. THE POWER SWITCHING BOARD ASSEMBLY PCBA WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS, BUT NO FUNCTIONAL PROBLEM WAS FOUND DURING TESTING. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA NEW ENGLAND DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO (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 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 THE 2D IMAGES TAKEN WITH THE IMAGING SYSTEM APPEARED GRAINY DURING A KYPHOPLASTY SPINE PROCEDURE. THE IMAGES DID NOT CONTAIN ARTIFACT. THE SURGEON WAS NOT USING NAVIGATION FOR THE SURGERY. THE 2D IMAGES WITH AUTOMATIC SETTING HAD A KV VALUE OF 100-107KV. THE RADIOLOGIC TECHNOLOGIST (RT) ADJUSTED THE CONTRAST AND OTHER SETTINGS FOR THE 2D IMAGES. THE SURGEON USED THESE IMAGES TO COMPLETE THE SURGERY. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE, AND NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731983 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 45 YR