BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CART 9733856 S7 STAFF ASSEMBLED 110V

    MDR report key: 9580591 · Received January 13, 2020

    Report

    Report Number
    1723170-2020-00118
    Event Type
    Malfunction
    Date Received
    January 13, 2020
    Date of Event
    December 17, 2019
    Report Date
    February 3, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE COMPUTER WAS RETURNED FOR ANALYSIS. FUNCTIONAL TESTING DETERMINED THAT THE COMPUTER BOOTS NORMALLY TO THE APPLICATION SCREEN. THE ENT AND SPINE PROGRAMS START AND RUN NORMALLY. NO FAN CYCLING WAS OBSERVED ON THE COMPUTER. NO "NO SIGNAL" MESSAGES WERE OBSERVED. CODES ASSOCIATED WITH THE COMPUTER: FDR 213, FDC 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.

    Additional Manufacturer Narrative · 1

    ONSITE FUNCTIONAL AND VISUAL EXAMINATION WAS PERFORMED BY A MANUFACTURER REPRESENTATIVE. THE COMPUTER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE SYSTEM PASSED A SYSTEM CHECKOUT AND WAS RETURNED TO AN OPERATIONAL CONDITION. THE COMPUTER WAS RETURNED FOR ANALYSIS. HOWEVER, ANALYSIS WAS NOT COMPLETED AT THE TIME OF FILING. OTHER RELEVANT DEVICE(S) ARE: COMPUTER 9734477 ROLLINGSTONE EMB., LOT NUMBER: 1832017. 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 DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM BOOTS INTO NO SIGNAL EVERY TIME AND THEN POWER CYCLES. THE FANS WERE HEARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46922 CART 9733856 S7 STAFF ASSEMBLED 110V INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1