BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM SYS BI70002000 O2 CD 120V B EN EN

    MDR report key: 8181932 · Received December 19, 2018

    Report

    Report Number
    3006544299-2018-00027
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    November 26, 2018
    Report Date
    February 21, 2019
    Manufacturer
    SANMINA -SCI SYSTEMS
    Product Code
    OWB
    UDI-DI
    00763000132378
    PMA / PMN Number
    K151000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IF FOLLOW-UP, WHAT TYPE IT WAS DETERMINED THERE WAS AN ACCIDENTAL RADIATION OCCURRENCE DUE TO EARLY TERMINATION OF ACQUISITION. NO DEFECT IN AN ELECTRONIC PRODUCT OR FAILURE WAS DISCOVERED. THE INVESTIGATION IS INCONCLUSIVE. UNABLE TO DETERMINE THE ROOT CAUSE BASED ON THE DOCUMENTED INFORMATION. NUMBER OF PEOPLE EXPOSED: 1 - PATIENT TOTAL NUMBER OF PEOPLE IN OR UNKNOWN ESTIMATED 3D DOSE ABSORBED (PATIENT): 11.20MSV 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. 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 ISSUE WAS DETERMINED TO BE DUE TO THE NAVIGATION DEVICE HAVING THE WRONG DATE. THE IMAGING SYSTEM PASSED A SYSTEM CHECKOUT AND WAS DETERMINED TO BE FULLY OPERATIONAL. 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 FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SITE TOOK A SPIN AND THE IMAGES SHOWED THE NAV TAG, BUT THE IMAGES DID NO AUTO-TRANSFER TO THE NAVIGATION SYSTEM. THE SITE WAS UNABLE TO MANUALLY PUSH THE IMAGES. THE SITE ATTEMPTED A SECOND SPIN, BUT THE SAME ISSUE OCCURRED. THERE WAS A MESSAGE ON THE MOBILE VIEW STATION (MVS) STATING IT DID NOT SUPPORT THE IMAGE TYPE. THERE WAS ALSO AN ERROR SHOWING THE NAVIGATION SYSTEM STATING THEY NEEDED TO MANUALLY REGISTER, BUT THE PATIENT EXAM WAS NOT PRESENT. ADDITIONAL INFORMATION WAS RECEIVED: THE SITE TOOK ANOTHER SPIN WITH A DIFFERENT SYSTEM AND WERE ABLE TO PROCEDURE WITH THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017826 O-ARM SYS BI70002000 O2 CD 120V B EN EN INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SANMINA -SCI SYSTEMS BI70002000 00763000132378

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR