BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 18987172 · Received March 27, 2024

    Report

    Report Number
    3006544299-2024-00245
    Event Type
    Malfunction
    Date Received
    March 27, 2024
    Date of Event
    March 22, 2024
    Report Date
    April 24, 2024
    Manufacturer
    SANMINA -SCI SYSTEMS
    Product Code
    OWB
    UDI-DI
    00763000355555
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: M021083C001, SOFTWARE VERSION: 4.2.1; PRODUCT ID: BI71000424; PRODUCT ID: BI71000167. H3, H6: NO HARDWARE PARTS HAVE BEEN RETURNED FOR ANALYSIS. B17, C20, D15 ARE APPLICABLE. H6: MULTIPLE ANNEX G CODES WERE REPORTED. G02008 CORRESPONDS TO CONCOMITANT PRODUCT SOFTWARE THAT COMPRISES THE REPORTED EVENT. G040 18CORRESPONDS TO CONCOMITANT PRODUCT MVS TO IAS CABLE THAT COMPRISES THE REPORTED EVENT. G04096 CORRESPONDS TO CONCOMITANT PRODUCT PANEL REAR CABINET BRACKET THAT COMPRISES THE REPORTED EVENT. H6: MULTIPLE FDD/ANNEX A CODES WERE REPORTED. A09 WAS CODED FOR THE LIGHT OVER THE BRAKE AND IMAGE REVERSE BUTTONS WOULD BLINK WHEN GANTRY MOTION BUTTONS DEPRESSED. A090501 WAS CODED FOR THE SYSTEM NOT BEING ABLE TO EXPOSE. A150204 WAS CODED FOR THE GANTRY NOT MOVING IN X, Y, OR Z AXES AND NOT BEING ABLE TO TILT. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H2) PLEASE SEE SECTION B5 AND A3B FOR ADDITIONAL INFORMATION. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H3, H6) THE SYSTEM WAS SERVICED IN THE FIELD AND THE COMPLAINT WAS VERIFIED. WHILE PRESSING THE WAG BUTTON, THE UNIT WENT INTO "DISABLE X-RAY" MODE. THE GANTRY MOVED FROM POSITION 0 TO 193 BUT DID NOT WAG. THE SYSTEM WAS REBOOTED AND WHILE FLEXING THE INTERCONNECT CABLE, IT WAS FOUND THAT THE CABLE WAS CAUSING THE ISSUE. THE CABLE WAS REPLACED. INVALIDATE HOME PROCEDURE WAS THEN PERFORMED AND SEVERAL X-RAY SHOTS WERE TAKEN. THE SYSTEM THEN PERFORMED AS INTENDED. CODES B01, C07, AND D02 ARE APPLICABLE TO THIS SYSTEM SERVICING. H3, H6) THE PRODUCT ID: BI71000167, LOT NUMBER: 932 REV. D, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND ANALYSIS DID NOT CONFIRM THE REPORTED EVENT, "UNABLE TO MOVE GANTRY". THE CABLE PASSED A BENCH TEST. CONTINUITY ALSO PASSED AND THE CABLE WAS INSTALLED INTO A TEST IMAGING SYSTEM. THE SYSTEM PASSED ALL TESTING. IT WAS REPORTED THE CABLE WAS MISSING A COVER LOCKING LEVER, HOWEVER. CODES B01, C07, AND D02 ARE APPLICABLE TO THIS RETURNED PRODUCT ANALYSIS. H3, H6) A SOFTWARE ANALYSIS WAS INITIATED, HOWEVER, THE REPORTED COMPLAINT WAS NOT CONFIRMED. THE RESULTS OF ANALYSIS CONCLUDED THE ISSUE WAS RELATED TO A HARDWARE ISSUE AS PER SYSTEM SERVICING. CODES B01, C19, AND D14 ARE APPLICABLE. H2) THE PRODUCT ID: BI71000424, LOT NUMBER: 0011988061, WAS RETURNED UNUSED TO THE MANUFACTURER. THIS PRODUCT IS NO LONGER ASSOCIATED WITH THIS COMPLAINT. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING AN LEFT DEEP BRAIN STIMULATION (DBS) LEAD IMPLANTATION. IT WAS REPORTED THAT DURING A CASE THE GANTRY WAS UNABLE TO MOVE IN THE X, Y, OR Z AXES AND WOULD NOT TILT. WHEN THE GANTRY MOTION BUTTONS WERE DEPRESSED, THE MANUFACTURER REPRESENTATIVE REPORTED THE LIGHT OVER THE BRAKE AND IMAGE REVERSE BUTTONS WOULD BLINK. ONCE THE GANTRY MOTION BUTTONS WERE NO LONGER BEING PRESSED, THE LIGHTS WOULD STOP BLINKING. THE SYSTEM WAS UNABLE TO EXPOSE DURING ISSUE OCCURRENCE. THE MANUFACTURER REPRESENTATIVE REBOOTED THE SYSTEM AND THE ISSUE WAS RESOLVED. THE ISSUE OCCURRED AGAIN AFTER THE PATIENT WAS REMOVED FROM THE ROOM AND THE SYSTEM WAS BEING PREPPED FOR ANOTHER PROCEDURE. THE SITE HAD ACQUIRED 2D AND 3D PHANTOM SHOTS AT THE BEGINNING OF THE DAY, WITH NO ISSUES FOUND DURING THIS PROCESS. A REGISTRATION SPIN WAS ACQUIRED WITHOUT ISSUE, AND THE SYSTEM WAS LEFT POWERED ON WITH THE IMAGE ACQUISITION SYSTEM (IAS) AND MOBILE VIEW STATION (MVS) CONNECTED TOGETHER AND TO WALL POWER FOR 20-30 MINUTES, THEN AFTER THESE ISSUE OCCURRED. THERE WAS NO ERROR MESSAGES NOTED ON THE IAS OR MVS DURING THE ISSUE OCCURRENCE. THERE WAS NO SURGICAL DELAY, AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. THE ISSUE OCCURRED INTRA-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488351 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SANMINA -SCI SYSTEMS BI70002000 00763000355555

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female