BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 21478686 · Received February 27, 2025

    Report

    Report Number
    3006544299-2025-00210
    Event Type
    Malfunction
    Date Received
    February 27, 2025
    Date of Event
    November 7, 2023
    Report Date
    February 27, 2025
    Manufacturer
    SANMINA -SCI SYSTEMS
    Product Code
    OWB
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA: 624392. D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: BI71000194, F1908: DELAY OF LESS THAN ONE HOUR F26: NO PATIENT IMPACT G2: THIS EVENT OCCURRED IN PORTUGAL, SEE SECTION E. H6: THE SYSTEM WAS SERVICED IN THE FIELD. HARDWARE PARTS WERE REPLACED. CODES B01, C13, AND D02 ARE 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR A HIP TUMOR RESECTION PROCEDURE. IT WAS REPORTED THAT THE 3D ACQUISITION COULD NOT BE PERFORMED WITH THE HANDSWITCH. 2D SCANS (AP AND LATERAL) WERE PERFORMED USING THE HANDSWITCH. WHEN CHANGED TO 3D MODE, WHILE PRESSING THE HANDSWITCH (MIDDLE BUTTON), THE GREEN LIGHT ON THE MOBILE VIEW STATION (MVS) WOULD START BLINKING AND THEN NOTHING HAPPENED. THE GREEN LIGHT JUST BLINKED WHILE THE BUTTON WAS BEING PRESSED. AFTER SOME TROUBLESHOOTING THE SITE TRIED THE 3D ACQUISITION WITH THE FOOTSWITCH, AND IT WORKED. DURING TROUBLESHOOTING THE SITE TRIED UNPRESSING AND PRESSING THE BUTTON AGAIN. THE GREEN LIGHT WOULD BLINK BUT 3D WAS UNSUCCESSFUL. THEY TRIED ROTATING THE TUBE/DETETOR IN THE 2D MODE, AND THEN BACK TO THE 3D MODE. THE GREEN LIGHT WOULD BLINK BUT 3D WAS STILL UNSUCCESSFUL. 2D SCANS WITH THE HANDSWITCH WAS TRIED AGAIN AND THEN BACK TO THE 3D MODE. THE GREEN LIGHT WOULD BLINK BUT 3D WAS STILL UNSUCCESSFUL. THEY REBOOTED THE IMAGE ACQUISITION SYSTEM (IAS) AND MVS AND TRIED AGAIN BUT THE GREEN LIGHT WOULD BLINK BUT 3D WAS UNSUCCESSFUL. THEY CONNECTED THE FOOTSWITCH AND 3D WAS SUCCESSFUL. AFTER THIS THEY TRIED AGAIN WITH THE HANDSWITCH THE GREEN LIGHT WOULD BLINK BUT 3D UNSUCCESSFUL. THE NEXT STEP WAS TO PERFORM A 3D SCAN WITH THE FOOTSWITCH. THERE WAS LESS THAN AN HOUR DELAY TO THE CASE. NO REPORTED IMPACT TO THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1326759 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SANMINA -SCI SYSTEMS BI70002000

    Patients

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