BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5975328 · Received September 23, 2016

    Report

    Report Number
    1723170-2016-04452
    Event Type
    Malfunction
    Date Received
    September 23, 2016
    Date of Event
    December 22, 2015
    Report Date
    September 23, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 FIELD SERVICE ENGINEER WENT TO SITE AND REPLACED THE MVS POWER BOARD, UPS, AND MVS POWER CORD ON 12/23/2015 AS THOSE PARTS WERE SHIPPED TO SITE ON 12/22/2015. THE PARTS WERE SHIPPED BACK TO MANUFACTURER AND ANALYZED: THE ANALYSIS OF THE PCBA MVS POWER BOARD ASSEMBLY CONFIRMED THE REPORTED PROBLEM "BOARD FUSES BLEW TWICE IN A ROW. PREVENTED MVS FROM POWERING ON." MVS POWER BOARD WAS PRESENTED WITH OPEN F11. F9, F10, AND F12 GOOD. FAILURE MECHANISM: BLOWN FUSE(S). THE ANALYSIS OF THE MVS POWER CORD CONFIRMED REPORTED PROBLEM "AC CABLE PLUG HAS BENT PINS AND CORD IS DISFIGURED" AC CABLE HAS BENT PINS ON AC PLUG, ALSO A SPIRAL TYPE TWIST APPEARS IN THE CABLE ITSELF. FAILURE MECHANISM: CONNECTOR-DAMAGED, PIN BENT OR MISSING. THE ANALYSIS OF THE UPS POWER SUPPLY CONFIRMED REPORTED PROBLEM "BATTERY BACK UP TIME SHORT" UPS FAILED 5 MIN LOAD TEST IN 3 MIN 7 SEC. FAILURE MECHANISM: BATTERY WON'T HOLD CHARGE. THE IMAGING SYSTEM WAS TESTED AFTER PARTS WERE REPLACED, AND A CHECKOUT WAS PERFORMED. EVERYTHING PASSED AND SYSTEM WAS PUT BACK INTO SERVICE. NO FURTHER ISSUES REPORTED. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(6) DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 (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 MVS WILL NOT BOOT. IT WAS NOTED THAT THE LINE POWER LIGHT WAS NOT ON AND NO NOISE WAS COMING FROM THE SYSTEM. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624492 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