BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 12476510 · Received September 15, 2021

    Report

    Report Number
    3006544299-2021-00351
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Date of Event
    August 25, 2021
    Report Date
    November 1, 2021
    Manufacturer
    SANMINA -SCI SYSTEMS
    Product Code
    OWB
    UDI-DI
    00763000355555
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE MOBILE VIEW STATION (MVS) POWER BOARD WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND THAT THE REPORTED ISSUE COULD NOT BE CONFIRMED. NO FAILURE WAS FOUND WITH IT WHILE UNDER TESTING. 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

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE SYSTEM. FOUND FREQUENT ERRORS ORIGINATING FROM THE MVS (MOBILE VIEWING STATION) POWER CONTROLLER. THE MVS POWER CONTROLLER REPLACED. WHEN ONSITE, THE MVS MONITOR WOULD NOT TURN ON. THE DISPLAY WAS CRACKED AND DID NOT TURN ON. REPLACED THE MVS MONITOR TO RESOLVE THE ISSUE. PHYSICAL INSPECTION PERFORMED AND NO ISSUES WERE FOUND. FULL SYSTEM CHECKOUT PERFORMED. SYSTEM WAS FULLY FUNCTIONAL. CONTINUATION OF CONCOMITANT PRODUCTS: INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: BI71000181,( PCBA MVS POWER) SERIAL/LOT #: (B)(4), UBD: , UDI#: ; PRODUCT ID: BI71000173( DISPLAY M-GRD 30IN)SERIAL/LOT #: (B)(4), UBD: , UDI#: ; PRODUCT ID: BI71000164 (MVS ETHERNET COUPLER) SERIAL/LOT #: -, UBD: , UDI#: A HARDWARE ANALYSIS WAS INITIATED TO DETERMINE THE PROBABLE CAUSE OF THE ISSUE. ANALYSIS FOUND PRODUCT ID BI71000173( DISPLAY M-GRD 30IN) DISPLAYING LINES ON THE SCREEN WHEN IT WAS ON." MVS MONITOR FAILED BENCH TEST. VISUAL INSPECTION CONFIRM DAMAGE MONITOR. BROKEN INTERNAL LCD SCREEN. FOR PRODUCT ID: BI71000181,( PCBA MVS POWER),IT WAS RETURNED NO ANALYSIS WAS PERFORMED AND IT WAS SCRAPED. THE FOLLOWING CODES APPLY TO PRODUCT BI70002000 (BASE SYS O-ARM SYS O2) SERIAL# (B)(4) FDM B01, FDR C07, FDC D02 THE FOLLOWING CODES APPLY TO PRODUCT ID: BI71000173( DISPLAY M-GRD 30IN)SERIAL/LOT #: (B)(4), UBD FDM B01, FDR C07, FDC D02.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHILE ATTEMPTING TO TAKE A POST-OP SPIN, THE IMAGING ACQUISITION SYSTEM HAD DIFFICULTY BOOTING, GIVING A BATTERY ERROR, AND THE MOBILE VIEWING STATION POWERED OFF IMMEDIATELY AFTER BOOTING UP. THE IMAGING ACQUISITION SYSTEM WAS ABLE TO BE TURNED ON AND STAYED ON, BUT THE MOBILE VIEWING STATION MONITOR APPEARED TO BE CUTTING IN AND OUT AND WAS DISPLAYING LINES ON THE SCREEN WHEN IT WAS ON. USED IMAGING FOR A POST-OP SPIN. THE WAS NO IMPACT TO THE PATIENT OUTCOME AND THE WAS NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375025 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SANMINA -SCI SYSTEMS BI70002000 00763000355555

    Patients

    Seq Age Sex Outcome Treatment
    1