BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASE SYS BI70002000 O-ARM SYS O2

    MDR report key: 9842311 · Received March 17, 2020

    Report

    Report Number
    3004785967-2020-00374
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    March 13, 2020
    Report Date
    May 19, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OWB
    UDI-DI
    00763000068066
    PMA / PMN Number
    K151000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H2/H3/H6: THE MOBILE VIEWING STATION (MVS) COMPUTER WAS RETURNED AND ANALYZED. THE COMPUTER PASSED BENCH TESTS. THE OS AND APPLICATION LOADED SUCCESSFULLY. A VIRUS SCAN AND PATIENT DATA WAS COMPLETED WITH NO ISSUES. THE MVS WAS INSTALLED IN A TEST SYSTEM. THE SYSTEM DID NOT INITIALIZE. ON THE PENDANT THE GENERATOR AND COMMUNICATION FAILED. THERE WAS NO COMMUNICATION BETWEEN THE MVS AND IMAGE ACQUISITION STATION (IAS) COMPUTER. IT WAS UNABLE TO ACCESS THE REMOTE DESKTOP. CODES 10, 120 AND 4307 ARE APPLICABLE. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: KIT SVC BI71000475 MVS INTERFACE, LOT NUMBER: REV. 1 : S/N 2062528 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 · 0

    H2/H3/H6: THE IMAGE ACQUISITION STATION (IAS) COMPUTER WAS RETURNED AND ANALYZED. THE COMPUTER PASSED BENCH TESTING. THE APPLICATIONS LOADED SUCCESSFULLY AND A VIRUS SCAN WAS COMPLETED. THE COMPUTER WAS INSTALLED IN A TEST SYSTEM AND THE SYSTEM INITIALIZED, MOTION CALIBRATION PASSED AND MOTION, GENERATOR, COMMUNICATION AND CHARGING ALL READIED. BOTH 2D AND 3D IMAGING WAS SUCCESSFUL. NO FAILURES WERE FOUND. CODES 10, 213 AND 67 ARE APPLICABLE TO THIS ANALYSIS. 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

    ONSITE FUNCTIONAL AND VISUAL EXAMINATION WAS PERFORMED BY A MANUFACTURER REPRESENTATIVE. THE MOBILE VIEW STATION (MVS) AND IMAGE ACQUISITION SYSTEM (IAS) COMPUTER WERE REPLACED AND THE ISSUE WAS RESOLVED. THE SYSTEM PASSED A SYSTEM CHECKOUT AND WAS RETURNED TO AN OPERATIONAL CONDITION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN THE SYSTEM WAS BOOTED UP THE SYSTEM WAS STUCK IN STAND ALONE MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305423 BASE SYS BI70002000 O-ARM SYS O2 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC (LITTLETON) BI70002000 00763000068066

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10