BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 9438642 · Received December 9, 2019

    Report

    Report Number
    3004785967-2019-02099
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Date of Event
    November 19, 2019
    Report Date
    January 28, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE PCBA BI31000118 HT CONTROLLER PCB (MT1011898 / G35402) WAS RETURNED FOR ANALYSIS. ANALYSIS FOUND NO FAULT WITH THE RETURNED CONTROLLER. THE CONTROLLER WAS INSTALLED IN A TEST SYSTEM AND THE SYSTEM INITIALIZED. MOTION, GENERATOR, COMMUNICATION, AND CHARGING READIED. RUN FLUORO GAIN AND RUN RAD GAIN CALIBRATIONS PASSED; 2D AND 3D IMAGES WERE SUCCESSFUL. EVALUATION CODES THAT APPLY TO THIS TESTING: 10, 213, 67. THE PCBA BI31000120 INTFC CTRL R F W/O HV (MT1015331 / G35402) WAS RETURNED FOR ANALYSIS. ANALYSIS FOUND NO FAULT WITH THE RETURNED INTERFACE CONTROL BOARD. THE INTERFACE CONTROL BOARD WAS INSTALLED IN A TEST SYSTEM AND THE SYSTEM INITIALIZED. MOTION, GENERATOR, COMMUNICATION, AND CHARGING READIED. RUN FLUORO GAIN AND RUN RAD GAIN CALIBRATIONS PASSED; 2D AND 3D IMAGES WERE SUCCESSFUL. EVALUATION CODES THAT APPLY TO THIS TESTING: 10, 213, 67. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. THE UNIQUE IDENTIFIER WAS NOT AVAILABLE AT THE TIME OF REPORTING. THE MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE IMAGING SYSTEM. THE REPORTED ISSUE WAS CONFIRMED AND THE HT CONTROL BOARD AND GENERATOR INTERFACE BOARD WERE REPLACED. AFTER REPLACEMENT THE SYSTEM PASSED ALL TESTING. THE MANUFACTURE DATE WAS NOT AVAILABLE AT THE TIME OF REPORTING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SYSTEM DID NOT TRANSFER IMAGES AND NEEDED TO BE REBOOTED MULTIPLE TIMES TO CONTINUE THE PROCEDURE. THERE WAS A MESSAGE ON THE SYSTEM STATING THE IMAGE FRAME RATES WERE BELOW THE RECOMMENDED LEVEL. THERE WAS LESS THAN AN HOUR DELAY IN THE PROCEDURE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234207 O-ARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC (LITTLETON) 9732719

    Patients

    Seq Age Sex Outcome Treatment
    1