BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 20699386 · Received November 15, 2024

    Report

    Report Number
    3006544299-2024-00931
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    February 29, 2024
    Report Date
    November 15, 2024
    Manufacturer
    SANMINA -SCI SYSTEMS
    Product Code
    OWB
    UDI-DI
    00763000132378
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. A090501: NAVIGATION DISABLED. A1102: WARNING MESSAGE. F26: NO PATIENT IMPACT. F1908: DELAY OF LESS THAN ONE HOUR. H3, H6: NO PRODUCTS HAVE BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 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. 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 A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT BEFORE A SPIN OF A PATIENT, THE MOBILE VIEW STATION (MVS) SHOWED A WARNING MESSAGE THAT SAID "FLUORO GAIN CALIBRATION RECOMMENDED. FILE NOT FOUND. STANDARD RAD GAIN CALIBRATION IS RECOMMENDED. FILE NOT FOUND. EXTENDED RAD GAIN CALIBRATION RECOMMENDED. FILE NOT FOUND." AFTER CLICKING ON 'OK,' A NEW WARNING MESSAGE APPEARED: "O-ARM NAVIGATION DISABLED. APPLICATION REQUIRES VALID GEOMETRY CALIBRATION FILE." THEY TRIED TO REBOOT THE SYSTEM, WHICH RESOLVED THE ISSUE. THE TOTAL DELAY WAS ABOUT 7 MIN. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43576 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SANMINA -SCI SYSTEMS BI70002000 00763000132378

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown