BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6005334 · Received October 6, 2016

    Report

    Report Number
    1723170-2016-04475
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    August 25, 2015
    Report Date
    October 6, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC REPRESENTATIVE WENT TO SITE TO TROUBLESHOOT ISSUE ON 8/26/2015. A REPLACEMENT MOBILE VIEW STATION (MVS) CABLE, OPTICAL SWITCH CABLE AND MOTION CONTROL BOX WERE SENT TO SITE AND SWAPPED OUT. SYSTEM TESTED AND PASSED AFTER REPLACEMENT AND IMAGING SYSTEM PUT BACK INTO USE. PARTS WERE SENT BACK TO MANUFACTURER AND EVALUATED. MVS CABLE: CONFIRMED REPORTED PROBLEM "FRAME GRABBER ERRORS." DURING BENCH LEVEL TESTING IT WAS NOTED THAT THE 100T TEST FAILED, INDICATING COMMUNICATION ERRORS. FAILURE MECHANISM: FAULTY YELLOW CAT 5 CABLE. OPTICAL SWITCH CABLE: CONFIRMED REPORTED PROBLEM "SYSTEM ASKED THE USER TO RE-HOME THE SYSTEM, THEN SHUT DOWN." UPON VISUAL INSPECTION, IT WAS NOTED AN AREA OF THE CABLE HARNESS IS CRIMPED AND FLEXING WILL RESULT IN THE SYSTEM REQUIRING REHOMING. FAILURE MECHANISM: CRIMPED WIRES. NO FURTHER ISSUES REPORTED. 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 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 CALLED IN AND REPORTED THE SYSTEM INITIALISED A SHUT DOWN. WHEN IT WAS REBOOTED, A MESSAGE POPPED UP TO ASK USER TO RE-HOME THE SYSTEM. AFTER, THE SYSTEM INITIALISED IT SHUT DOWN AGAIN. AFTER REBOOTING A COUPLE OF TIMES, SYSTEM STILL DID NOT WORK. THE REPRESENTATIVE READ THE LOGS WHICH IMPLIED THE UMBILICAL CORD AND GANTRY TILT WAS DAMAGED. NEXT STEP IS TO REPLACE UMBILICAL CORD, TILT HOME OPTICAL SWITCH AND GANTRY MOTION CONTROLLER BOX. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658493 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