BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 3603923 · Received February 3, 2014

    Report

    Report Number
    1723170-2014-00092
    Event Type
    Malfunction
    Date Received
    February 3, 2014
    Date of Event
    January 6, 2014
    Report Date
    August 28, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. REPLACEMENT PCBA CHARGE/DISCHARGE MONITOR AND PCBA INTFC CTRL R F W/O HV SHIPPED TO SITE. MEDTRONIC REPRESENTATIVE REPORTED THAT AFTER REPLACING THE CHARGE/DISCHARGE MONITOR BOARD AND INTERFACE CONTROL BOARD THE SYSTEM SEEMED TO BE WORKING FINE. PERFORMED FLUORO & RAD GAIN CAL AND ONE 3D SPIN. IN THE SECOND 3D SPIN, SYSTEM STOPPED, COULD NOT COMPLETE THE SCAN AND SHOWED E-STOP WAS PRESSED. OPENED THE CHARGER BOARD COVERS AND DETERMINED A CAPACITOR HAS BURN SPOT. RMAS ISSUED. NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    MEDTRONIC INVESTIGATION OF RETURNED SUSPECT CHARGE BOARD FINDS THAT THE CIRCUIT BOARD HAS SIGNIFICANT BURN UNDER RESISTORS DUE TO ELECTRICAL OVER STRESS. THE REPORTED EVENT WAS CONFIRMED TO BE CAUSED BY PHYSICAL DAMAGE OF THE CIRCUIT BOARD. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT INTERFACE CONTROL BOARD FINDS THAT THE REPORTED EVENT COULD NOT BE CONFIRMED. THE BOARD WAS INSTALLED IN THE O-ARM TEST SYSTEM AND RAN WITHOUT ANY ISSUES. UNABLE TO DUPLICATE REPORTED EVENT. AS PREVIOUSLY REPORTED THE ABOVE COMPONENTS WERE REPLACED THE RESOLVE THE ISSUE. NO FURTHER RELEVANT ISSUES REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHEN TURNING ON THE IMAGING SYSTEM DURING A TEST, A BURNING SMELL WAS DETECTED. THE SYSTEM WAS SHUT-OFF AND ALL SYSTEM PARTS AND COMPONENTS WERE CHECKED. THE SOURCE OF THE BURNING SMELL WAS FOUND TO BE COMING FROM THE DISCHARGE MONITOR BOARD. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70885 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