BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 20028554 · Received August 22, 2024

    Report

    Report Number
    3004785967-2024-00491
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 30, 2024
    Report Date
    October 18, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OWB
    UDI-DI
    00643169639683
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6) THE PRODUCT ID: BI71000576, LOT NUMBER: S1735AWZ REV. C, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS ON 2024-09-26. IN SUMMARY, NO FAULTS WERE FOUND. THE STARTER UPGRADE KIT WAS INSTALLED INTO A TEST IMAGING SYSTEM AND THE SYSTEM PERFORMED AS INTENDED. PREVIOUSLY REPORTED CODE, B01, IS APPLICABLE AS WELL AS NEWLY REPORTED CODE, C19 AND D14. H3, H6) THE PRODUCT ID: BI71000469, LOT NUMBER: T173329 REV. E, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS ON 2024-09-27. THE HIG H-VOLTAGE (HV) TANK PASSED BENCH TEST. THE RESISTANCE BETWEEN POINTS ON THE HV TANK PASSED. VISUAL INSPECTION CONFIRMED A SINGLE LONGITUDINAL CRACK IN THE CATHODE WELL. PREVIOUSLY REPORTED CODES B01, C07, AND D02 ARE APPLICABLE. H2) ADDITIONAL INFORMATION WAS RECEIVED. THE DUAL SPEED STARTER THAT WAS NOTED TO BE AN OUT-OF-FAILURE WAS RETURNED AND ITS LOT NUMBER IS S2038GKA. H3, H6) THE PRODUCT ID: BI71000222, LOT NUMBER: T1727AAL REV. F, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS ON 2024-09-26. IN SUMMARY, NO FAULTS WERE FOUND. THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) GENERATOR CONTROL WAS INSTALLED INTO A TEST IMAGING SYSTEM AND THE SYSTEM PERFORMED AS INTENDED. PREVIOUSLY REPORTED CODE, B01, IS APPLICABLE AS WELL AS NEWLY REPORTED CODE, C19 AND D14. H3, H6) THE PRODUCT ID: BI71000901, LOT NUMBER: 19101-M8 REV. 1, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS ON 2024-09-27. THE TUBE AND TANK WELLS WERE FOUND TO SHOW SIGNS OF DAMAGE. VISUAL INSPECTION CONFIRMED A DAMAGED HV TANK. DEEP CRACKS WERE FOUND IN THE CATHODE CHAMBER. STATOR RESISTANCE WAS WITHIN SPECIFICATION. PREVIOUSLY REPORTED CODES B01, C07, AND D02 ARE APPLICABLE. H3, H6) THE PRODUCT ID: BI71000416, LOT NUMBER: 180315603 REV. G, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS ON 2024-09-30. IN SUMMARY, NO FAULTS WERE FOUND. CANDLESTICKS AND X-RAY TUBE CABLE ASSEMBLY PASSED CONTINUITY TESTING. NO PROBLEMS WERE FOUND. PREVIOUSLY REPORTED CODE, B01, IS APPLICABLE AS WELL AS NEWLY REPORTED CODE, C19 AND D14. 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

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: B I71000576; PRODUCT ID: BI71000576; PRODUCT ID: BI71000416; PRODUCT ID: BI71000901 ; PRODUCT ID: BI71000469. H3, H6: THE SYSTEM WAS SERVICED IN THE FIELD BY A MEDTRONIC REPRESENTATIVE (REP). THE TUBE HAD NO OIL AND THE CATHODE ON THE SIDE HAD TWO CRACKS 2/3 OF THE WAY UP THE WELL. THE TANK HAD A DRY SPOT WHERE THE CANDLESTICK SEATED ON THE CATHODE END AND TWO CRACKS 2/3 OF THE WAY UP THE WELL. A DAMAGED SIDEWALL COVER, INNER GANTRY COVER, DIM DETECTOR, AND SOURCE LED WERE FOUND. THE X-RAY TUBE AND THE HV TANK WERE REPLACED. TUBE SEASONING WAS COMPLETED. ATTEMPTED A SPIN, THE SPIN TERMINATED EARLY, AND THE GENERATOR SHOWED E139. COMPLETED SEDECAL TROUBLESHOOTING FOR E139, AND DETERMINED THAT THE DUAL SPEED STARTER NEEDED TO BE REPLACED. REPLACED THE SOURCE AND DETECTOR LED BOARDS, THE RIGHT DOOR SIDEWALL COVER, AND THE LOWER INNER GANTRY COVER. REPLACED THE DUAL SPEED STARTER AND THE REP WAS STILL GETTING ERROR 139, VERIFIED VOLTAGES ON BOARD WERE GOOD, AND ALL CONNECTIONS WERE TIGHT. MARKED THE DUAL SPEED STARTER AS AN OUT OF BOX FAILURE. ALSO, THE REP WAS STILL SEEING ERRORS 40 AND 41, THOUGH THEY ARE NOT HAPPENING CONSISTENTLY. WHEN THE SCOPE PROBES WERE ATTACHED TO THE GENERATOR CONTROL BOARD, ONE OF THE MA TEST POINTS BROKE OFF THE BOARD. CODES B01, C07, C02, D02 AND D03 ARE APPLICABLE. FOR THE TUBE G04134 IS APPLICABLE, FOR THE TANK/GENERATORS G04060 IS APPLICABLE, FOR THE COVERS G04037 IS APPLICABLE, FOR THE LEDS G05005 IS APPLICABLE, FOR THE CABLE G02004, AND FOR THE GENERATOR CONTROL BOARD G02005 IS APPLICABLE. 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 - A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO SERVICE THE SYSTEM. CAPTURED KV WAVEFORM WITH SCOPE, SWAPPED HIGH VOLTAGE CABLES ON BOTH ENDS, CAPTURED WAVEFORM DURING ERROR STATE AGAIN. THE ISSUE MOVED WITH THE CABLE. RETURNED TO THE SITE. REPLACED THE GENERATOR CONTROL BOARD, AND THE GANTRY CABLE CHAIN. COMPLETED SOURCE, DETECTOR, AND COLLIMATOR ALIGNMENT PROCEDURES. COMPLETED GENERATOR CALIBRATIONS. COMPLETED DOSIMETRY TESTING. COMPLETED SYSTEM CHECKOUT. SYSTEM NOW PASSES ALL TESTS WITHOUT ERRORS, AND IS FULLY FUNCTIONAL AT THIS TIME. CODES B01, C02, D02 APPLY. EVALUATION OF THE RETURNED LED PCBAS BI71000216 LOT#S 081774101 REV. 3 AND 081774178 REV. 3 AND BI71000217 LOT#S 061767749 REV. 3 AND 061767745 REV. 3 FOUND THAT THE LEDS WERE NOT BRIGHTLY LIT. EVALUATION CODES B01, C02 D02 APPLY. 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 OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS PERFORMING PARTIAL SPINS, IT WOULD SPIN BUT WOULD STOP AND NOT COMPLETE THE SPIN. THE ISSUE OCCURRED WITH 3D SPIN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2286870 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC (LITTLETON) BI70002000 00643169639683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown "SEE H11....".