BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 10516470 · Received September 10, 2020

    Report

    Report Number
    3004785967-2020-01061
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Date of Event
    August 21, 2020
    Report Date
    September 24, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H2) ADDITIONAL INFORMATION: D11 UPDATED. H3) ANALYSIS ON THE RETURNED IMAGE ACQUISITION SYSTEM (IAS) COMPUTER FAILED THE BENCH TEST. IT FAILED TO LOAD APPLICATIONS AND THE BIOS WERE INCORRECT. CONTINUATION OF D11) PN: BI71000848 ; LN: REV. 3 : S/N (B)(6). 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

    CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: BI71000112, SERIAL/LOT #: (B)(4). S/N (B)(4), UBD: UNKNOWON, UDI#: UNKNOWN PRODUCT ID: BI31001255, SERIAL/LOT #: NONE, UBD: UNKNOWN, UDI#: UNKNOWN. MEDTRONIC REPRESENTATIVE VISITED THE SITE TO EVALUATE THE EQUIPMENT.THE REP REPLACED THE CMOS BATTERY IN THE IAS, BUT WAS INFORMED THAT THE IAS WAS STILL NOT BOOTING UP INTERMITTENTLY. THE REP HOOKED UP A MONITOR TO THE IAS AND SAW WHERE THE SOFTWARE IS STUCK IN DOS ASKING TO PRESS F1 TO CONTINUE OR DELETE TO ENTER SETUP AGAIN, SO A NEW IAS WAS ORDERED AND INSTALLED. THE SYSTEM WAS BOOTING PROPERLY AND RETURNED TO SERVICE. CODES 10, 120, AND 4307 ARE APPLICABLE. CONCOMITANT PRODUCT BI31001255 HAS NOT BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. CODES 4114, 3221, AND 4315 ARE APPLICABLE. CONCOMITANT PRODUCT BI71000112 WAS RECEIVED BY MEDTRONIC ON 2020-SEP-01, BUT HAS NOT BEEN ANALYZED. CODES 4118, 3233, AND 11 ARE APPLICABLE. 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 USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE IMAGE ACQUISITION STATION (IAS) WAS STUCK IN THE BOOT-UP PROCESS. ON THE PENDANT IT STATED "SYSTEM BOOTING PLEASE WAIT". THE KEYBOARD WAS PLUGGED IN AND 'F1' WAS HIT WHICH ALLOWED THE SYSTEM TO BOOT UP. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE KEY WAS IN THE ON POSITION AT THE TIME THE ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979212 O-ARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC (LITTLETON) 9732719

    Patients

    Seq Age Sex Outcome Treatment
    1