BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6070672 · Received November 1, 2016

    Report

    Report Number
    1723170-2016-03192
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    June 25, 2014
    Report Date
    November 1, 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

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE SYSTEM. WHILE PERFORMING AN IMAGING SYSTEM CHECK-OUT, THE MEDTRONIC REPRESENTATIVE, CONFIRMED THE MOTION CONTROLLER FAILED. THERE WASN¿T ENOUGH TORQUE TO OPEN DOOR. A REPLACEMENT GANTRY MOTION CONTROL BOX WAS SHIPPED TO THE SITE. AFTER REPLACING THE GANTRY MOTION CONTROL BOX THE MEDTRONIC REPRESENTATIVE PERFORMED AN IMAGING SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. AN EVALUATION OF THE RETURNED GANTRY MOTION CONTROL BOX WAS COMPLETED AT THE MEDTRONIC FACILITY, CONFIRMING THE REPORTED PROBLEM "DOOR WILL NOT OPEN, ROTOR WILL MOVE INTO POSITION BUT DOOR WILL NOT OPEN." GANTRY BOX WAS DETERMINED TO BE DEFECTIVE. 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 RECEIVED A REPORT FROM A SITE ALLEGING ISSUES WITH OPENING THEIR IMAGING SYSTEM DOOR. THE REPORT ORIGINATED WITH A SITE REPRESENTATIVE THEIR HEAD OF RADIOLOGY. THE SITE REPRESENTATIVE STATED THAT THERE IS A NOTICEABLE HESITATION FROM WHEN THE BUTTON IS PRESSED TO WHEN THE DOOR OPENS. SOMETIMES THE DOOR BUTTON NEEDS TO BE PRESSED MULTIPLE TIMES BEFORE THE DOOR OPENS. THIS ISSUE OCCURRED PRIOR TO SURGERY, NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720776 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