BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM 3RD EDITION

    MDR report key: 5932539 · Received September 7, 2016

    Report

    Report Number
    1723170-2016-02163
    Event Type
    Malfunction
    Date Received
    September 7, 2016
    Date of Event
    August 9, 2016
    Report Date
    January 20, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K092564
    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. RETURN REQUESTED FOR 3 SUSPECT PARTS. REPLACEMENT PCBA HT CONTROLLER, INTERFACE CONTROLLER RF W/O HV PCBA, AND PCB FILAMENT DRIVER PCBA WERE SHIPPED TO SITE ON 08/09/2016. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS. ON 08/10/2016 A MEDTRONIC REPRESENTATIVE PERFORMED AN IMAGING SYSTEM CHECK-OUT, ALL AREAS PASSED. CHANGED FILAMENT DRIVER PCB DUE TO ERROR 15. ISSUE WAS REPRODUCED ONCE, HOWEVER, AFTER SWITCHING FROM A SMALL TO A LARGE FILAMENT THE PROBLEM WAS RESOLVED. CHECKED ALL DOSE CHECKS, ALL CONNECTIONS INSIDE THE GENERATOR AND ANY IMPEDANCE TO THE HV CABLES. SYSTEM PERFORMED AS INTENDED. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 1

    THE REPLACEMENT INTERFACE CONTROLLER RF W/O HV PCBA WAS RETURNED UNUSED AS IT WAS UNRELATED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE REPLACEMENT PCBA HT CONTROLLER WAS RETURNED UNUSED AS IT WAS UNRELATED TO THE REPORTED EVENT. THE SUSPECT PCB FILAMENT DRIVER PCBA WAS RETURNED FOR EVALUATION AND IS CURRENTLY UNDER ANALYSIS.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF RETURNED SUSPECT PCB FILAMENT DRIVER PCBA WAS UNABLE TO REPLICATE THE REPORTED ISSUE. INSTALLED FILAMENT DRIVER PCBA IN TEST IMAGING SYSTEM. THE MOTION, GENERATOR AND COMMUNICATION READIED. 2D AND 3D IMAGING WERE SUCCESSFUL WHILE UNDER TEST. NO GENERATOR ERRORS WERE OBSERVED WHILE UNDER TEST. NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED RECEIVING A GENERATOR ERROR 15 ON A SITE'S IMAGING SYSTEM. THIS OCCURRED DURING A SYSTEM CHECK-OUT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584804 O-ARM 1000 IMAGING SYSTEM 3RD EDITION IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC. (LITTLETON) BI-700-00028-120

    Patients

    Seq Age Sex Outcome Treatment
    1