BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 10505813 · Received September 8, 2020

    Report

    Report Number
    3004785967-2020-01046
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    August 14, 2020
    Report Date
    October 29, 2020
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10/D11: KIT SVC BI71000534 ROTOR MOT CTRL 01 AMC, SERIAL/LOT NUMBER 12-193420 REV 4 H3/H6: A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. IT WAS REPORTED THAT SEVERAL HARDWARE COMPONENTS WERE REPLACED. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE MONITOR WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THERE WAS AN ELECTRICAL FAILURE WITH THIS COMPONENT. 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.

    Description of Event or Problem · 0

    IT IS BELIEVED THAT ISSUE IS CAUSED BECAUSE THE UNINTERRUPTED POWER SUPPLY (UPS) IS NOT SUPPLYING POWER TO THE MVS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: BI71000492, SERIAL/LOT #: UNKNOWN. THE DEVICE HAS NOT BEEN EVALUATED AT THIS TIME. 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 FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING A CASE, HE NOTICED THAT THE SYSTEM'S LINE IN LIGHT WAS NOT ILLUMINATED. HE WONDERED IF THEY COULD STILL USE THE SYSTEM FOR A CASE, THEY WERE RECOMMENDED THEY HOLD OFF SINCE THE SYSTEM WAS NOT RECEIVING OUTLET POWER. ALSO, WHILE ON THE CALL, THEY WERE BOOTING UP THE MOBILE VIEWING STATION (MVS). FIRST TIME HE GOT POWER ON, THEN HE DISCONNECTED TO SEE IF IT WOULD GO TO BATTERY BACKUP, BUT THE MVS TURNED OFF. HE TRIED BOOTING IT UP AGAIN AND IT WOULD NOT POWER ON. THE THIRD TIME HE TRIED POWERING ON THE MVS, IT BOOTED UP. THE LINE IN LIGHT WAS NOT ILLUMINATED THE ENTIRE TIME.THEY ABORTED IMAGING AND THERE WAS NO REPORTED DELAY. THERE WAS NO IMPACT TO PATIENT OUTCOME. THE CAUSE OF THE ISSUE WAS DUE TO THE AGE OF THE LED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965580 O-ARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC (LITTLETON) BI70000027120

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR