BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM 3RD EDITION

    MDR report key: 10511549 · Received September 9, 2020

    Report

    Report Number
    3004785967-2020-01055
    Event Type
    Malfunction
    Date Received
    September 9, 2020
    Date of Event
    August 17, 2020
    Report Date
    October 14, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K092564
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H3: A HARDWARE ANALYSIS OF BI30000554 WAS INITIATED TO DETERMINE THE PROBABLE CAUSE OF THE ISSUE. ANALYSIS CONFIRMED REPORTED COMPLAINT. THE IAS COMPUTER FAILED BENCH TEST. WAS UNABLE TO LOAD OS AND IAS APPLICATION. BIOS( TIME AND DATE) INCORRECT. KEY F1 REQUIRED TO BE PRESSED BEFORE THE SYSTEM BOOT. FDCCODES: 4307 FDMCODES: 10, FDRCODES: 104 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. 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

    CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: BI30000554, SERIAL/LOT #: (B)(4), S/N (B)(4). A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE COMPUTER WAS REPLACED. THE SYSTEM THEN PASSED A SYSTEM CHECKOUT. THE COMPUTER WAS RETURNED TO MEDTRONIC FOR ANALYSIS. ANALYSIS WAS NOT COMPLETED AT THE TIME OF FILING. 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 OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN THE CUSTOMER TRIED TO TURN THE MACHINE ON, THEY TURNED ON THE MOBILE VIEWING STATION (MVS) FIRST SUCCESSFULLY. THEN, WHEN TURNING ON THE IAS IT SHOWED THE MESSAGE "SYSTEM BOOTING PLEASE WAIT" AND DIDN'T MOVE TO THE NEXT PAGE. TROUBLESHOOTING WAS PERFORMED BY TRYING TO REMOTE TO THE IMAGE ACQUISITION SYSTEM (IAS) COMPUTER FROM MVS WITHOUT RESOLUTION. THEY CHECKED THE POWER ON THE IAS COMPUTER INSIDE THE IMAGING SYSTEM AND THE LED WAS ON. THE CHECKED THE LAN PORT 1 AND 2 ON THE IAS COMPUTER AND NO LED WAS BLINKING ON THAT. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT THE SUSPECTED CAUSE OF THE REPORTED EVENT WAS A MALFUNCTION INSIDE THE COMPUTER RESULTING IN THE MACHINE NOT BOOTING UP THE APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975685 O-ARM 1000 IMAGING SYSTEM 3RD EDITION IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC (LITTLETON) BI70000028230

    Patients

    Seq Age Sex Outcome Treatment
    1