BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6139771 · Received December 1, 2016

    Report

    Report Number
    1723170-2016-03254
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    March 31, 2015
    Report Date
    December 1, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    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 IMAGING SYSTEM EQUIPMENT AND REPLACE PARTS. (B)(4) COMPUTER AND POWER SWITCHING BOARD WERE REPLACED. SYSTEM THEN FULLY FUNCTIONAL. THE POWER SWITCHING BOARD WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. THE (B)(4) COMPUTER WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE HARDWARE INVESTIGATION CONFIRMED REPORTED PROBLEM "(B)(4) COMPUTER DC-IN PINS FOUND BROKEN". RETURNED COMPUTER HAD DAMAGED INPUT CONNECTOR MISSING, THE CONNECTOR THAT CONNECTS TO THE POWER SWITCHING BOARD WAS SOLDERED DIRECTLY TO THE BOARD AND WIRES WERE WRAPPED IN A BLACK TAPE. THE REPORTED EVENT WAS RELATED TO AN ELECTRICAL FAILURE MODE DUE TO A DAMAGED CONNECTOR. (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 'MOTION BATTERY DROPPED BELOW 90V ON THE IMAGING SYSTEM APPLICATION SCREEN INTERMITTENTLY CAUSING SYSTEM TO SHUT DOWN. MEASUREMENT ON MOTION BATTERIES FOUND BATTERIES AT 110V. (B)(4) COMPUTER DC-IN PINS FOUND BROKEN.' THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789565 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