BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM

    MDR report key: 8312684 · Received February 6, 2019

    Report

    Report Number
    3004785967-2019-00204
    Event Type
    Malfunction
    Date Received
    February 6, 2019
    Date of Event
    January 16, 2019
    Report Date
    February 20, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: PATIENT IDENTIFIER, WEIGHT. PATIENT INFORMATION RECEIVED; INITIAL REPORTER RECEIVED. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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. 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 IDENTIFIER NOT AVAILABLE FROM THE SITE. INITIAL REPORTER NOT KNOWN AT THE TIME OF REPORTING. THE MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE IMAGING SYSTEM. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE UNINTERRUPTIBLE POWER SUPPLY (UPS) BATTERY CARTRIDGE WAS REPLACED. A SYSTEM CHECKOUT WAS PERFORMED AND THE SYSTEM IS WORKING AS INTENDED. 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 SYSTEM BEING USED IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE MOBILE VIEW STATION (MVS) DIED AFTER GIVING A "REPLACE BATTERY" WARNING MESSAGE. THE MVS WOULD NOT BOOTUP, BUT THE IMAGE ACQUISITION SYSTEM (IAS) WOULD. THE LINE POWER LIGHT WAS ON WHEN THE SYSTEM WAS PLUGGED INTO THE WALL AND THE IAS BATTERY INDICATORS SHOWED FULL. THE SITE WAS USING THE C-ARM AND WANTED TO TRY USING THE IMAGING SYSTEM, BUT CONTINUED WITH THE C-ARM AFTER THE ISSUE. THERE WAS NO DELAY TO THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104774 O-ARM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC (LITTLETON) BI70000027120

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR