BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 20700095 · Received November 15, 2024

    Report

    Report Number
    3004785967-2024-00715
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    May 30, 2024
    Report Date
    November 15, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OWB
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. A090501: COULD NOT EXPOSE A110201: STUCK IN STANDALONE MODE F26: NO PATIENT IMPACT F1908: DELAY OF LESS THAN ONE HOUR H3,H6: THE SYSTEM WAS SERVICED IN THE FIELD BY A MEDTRONIC REPRESENTATIVE. NO FAILURES WERE FOUND. CODES B01, C19, AND D14 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 DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE IMAGE ACQUISITION SYSTEM (IAS) COULD NOT EXPOSE DUE TO BEING STUCK IN STANDALONE MODE. THE GANTRY WAS AROUND THE PATIENT AT THE TIME. THE USER REBOOTED THE SYSTEM, RESOLVED THE ISSUE, AND CONTINUED THE CASE USING THE IMAGING SYSTEM. THE DELAY WAS ABOUT 5 MINUTES. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73767 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC (LITTLETON) BI70002000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown