BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6117789 · Received November 21, 2016

    Report

    Report Number
    1723170-2016-04294
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    August 27, 2015
    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
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A SITE REPRESENTATIVE REPORTED THAT THEY WERE NOT ABLE TO FINALIZE 3D ACQUISITIONS. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. ONSITE INVESTIGATION WAS PREFORMED, AND THE FIELD SYSTEMS ENGINEER DISCOVERED THAT THE REPORTED EVENT WAS CAUSED BY AN IMAGE ACQUISITION SYSTEM (IAS) COMPUTER MALFUNCTION. REPLACEMENT OF THE IAS COMPUTER RESOLVED THE ISSUE. DURING ONSITE INVESTIGATION, THE FIELD SYSTEMS ENGINEER ALSO REPLACED THE FOLLOWING: MOTION BATTERIES, MOBILE VIEW STATION (MVS) COMPUTER, AND THE POWER SWITCHING BOARD. NO FURTHER ISSUES WERE REPORTED. ANALYSIS OF THE RETURNED MVS COMPUTER AND POWER SWITCHING BOARD COULD NOT CONFIRM ANY FAILURE AS THEY BOTH PASSED TESTING AND FUNCTIONED WITHOUT PROBLEMS. ANALYSIS OF THE RETURNED IAS COMPUTER CONFIRMED THE ELECTRICAL FAILURE AS THE ISSUE COULD BE REPLICATED DURING TESTING DUE TO A FAULTY PORT. REPLACED MOTION BATTERIES WERE NOT RETURNED TO MANUFACTURER FOR ANALYSIS, THEREFORE, NO FINDINGS WILL BE POSSIBLE. A FULL IMAGING SYSTEM CHECK-OUT WAS COMPLETED AND ALL TESTS PASSED. FULL SYSTEM FUNCTIONALITY WAS CONFIRMED AND THE SYSTEM WAS RETURNED TO SERVICE. (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 THEY WERE NOT ABLE TO FINALIZE 3D ACQUISITIONS. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767725 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