BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6119045 · Received November 21, 2016

    Report

    Report Number
    1723170-2016-04557
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    September 15, 2014
    Report Date
    November 21, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO SITE TO TROUBLESHOOT ISSUE. IT WAS FOUND NO MOTION UP OR DOWN IN Y AXIS. Y DRIVE WAS ORDERED AND WHEN REPLACED DISCOVERED FAULTY POSITIONER MOTION CONTROLLER. MOTION CONTROLLER WAS ORDERED AND REPLACED. SYSTEM TESTED AFTER REPLACEMENT AND PERFORMED AS INTENDED, PASSED ALL TESTING AND PUT BACK INTO USE. THE Y DRIVE AND MOTION CONTROLLER WERE SENT BACK TO THE MANUFACTURER FOR EVALUATION. MOTION CONTROLLER BOX- CONFIRMED REPORTED PROBLEM "NO MOTION IN Y AXIS." POSITIONER WAS INSTALLED IN TEST SYSTEM AND OT DIDN'T MOVE AND MADE CLUNKING NOISE WHEN PENDANT KEYS WERE PRESSED TO MOVE IN Y-DIRECTION. Y-DRIVE ASSEMBLY-COULD NOT CONFIRM REPORTED PROBLEM "REPORTED THAT WHEN RAISING AND LOWERING THE GANTRY A LOUD 'THUMP' IS HEARD." REPORTED PROBLEM WAS DUE TO DEFECTIVE POSITIONER BOX RECEIVED ALONG WITH Y-DRIVE. NO FURTHER ISSUES REPORTED. (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 SITE REPRESENTATIVE REPORTED THAT WHEN RAISING AND LOWERING THE GANTRY A LOUD 'THUMP' IS HEARD. THE SYSTEM IS STILL FUNCTIONAL AND THEY WILL USE IT FOR UPCOMING CASES BY MOVING THE BED IN RELATION TO THE FIXED IMAGING SYSTEM. PROBABLE CAUSE- X-STAGE COVER IS CATCHING THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768237 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