BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 6135256 · Received November 30, 2016

    Report

    Report Number
    1723170-2016-05280
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    January 14, 2016
    Report Date
    May 19, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OWB
    PMA / PMN Number
    K151000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT GFI TRAP WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. TESTING FOUND THAT THE CURRENT RELAY THRESHOLD WAS SUFFICIENT TO CAUSE FALSE CURRENT FLOW INDICATIONS.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE REPRESENTATIVE CONFIRMED THAT ISSUES WITH THE GFI TRAP HAD OCCURRED. THE REPRESENTATIVE REPORTED THAT THE GFI TRAP WAS REPLACED ON (B)(6) 2016. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE GFI TRAP HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. (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 IMAGING SYSTEM BEGAN TO BEEP AFTER STARTING UP THE SYSTEM. THE X-RAY SELF TEST DID NOT COMPLETE. THE GENERATOR INTERFACED DISPLAYED AN ERROR. THE REPRESENTATIVE CLEARED THE GFI TRAP VIA COMMANDS IN THE COMMAND LINE OF THE IMAGING SYSTEM APPLICATION WHICH RESOLVED THE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786491 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC. (LITTLETON)

    Patients

    Seq Age Sex Outcome Treatment
    1