BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 21599015 · Received March 13, 2025

    Report

    Report Number
    3006544299-2025-00265
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    April 24, 2024
    Report Date
    March 13, 2025
    Manufacturer
    SANMINA -SCI SYSTEMS
    Product Code
    OWB
    UDI-DI
    00763000616564
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS SERVICED IN THE FIELD AND FAILED TESTING. THE GENERATOR WAS NOT BOOTING. TROUBLESHOOTING FOUND THAT THE STANDALONE BOARD WAS NOT FUNCTIONING AND HAD PHYSICAL DAMAGE (AN ELECTRICAL COMPONENT FAILURE). THE STANDALONE BOARD WAS REPLACED AND THE FAILURE WAS RESOLVED. THE SYSTEM WAS FULLY FUNCTIONAL. CODES B01, C02, AND D02 ARE APPLICABLE. THE STANDALONE BOARD WAS RETURNED AND ANALYZED. THE REPORTED COMPLAINT WAS CONFIRMED. VISUAL INSPECTION SHOWED THAT COMPONENT R21 WAS ELECTRICALLY OVER STRESSED. THE BOARD WAS UNABLE TO BE BENCH TESTED DUE TO OVER STRESSED COMPONENTS. CODES B01, C02, AND D02 ARE APPLICABLE. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: B I71000225R, SERIAL/LOT #: (B)(6) EFQ REV. T, UBD: , UDI#: THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 626390. 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 IMAGING SYSTEM WAS NOT CONNECTING WITH THE NAVIGATION SYSTEM. A MEDTRONIC REPRESENTATIVE (REP) WENT ONSITE AND FOUND THE IMAGING SYSTEM WASN¿T FULLY BOOTING. NO PATIENT WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481513 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SANMINA -SCI SYSTEMS BI70002000 00763000616564

    Patients

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