BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, X-RAY, FLUROSCOPIC, IMAGE-INTENSIFIED

    MDR report key: 11737027 · Received April 28, 2021

    Report

    Report Number
    11737027
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    March 22, 2021
    Report Date
    April 14, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OXO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    O-ARM NOT FUNCTIONING PROPERLY WHEN CASE WAS BEING SET UP. SALES REP WAS UPDATING SYSTEM WHEN IT ENDED UP CRASHING AND THEY HAD TO CALL THEIR TECH IN TO CORRECT IT ISSUE. THIS WAS A SOFTWARE ISSUE. CASE HAD TO BE RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637444 SYSTEM, X-RAY, FLUROSCOPIC, IMAGE-INTENSIFIED OXO MEDTRONIC NAVIGATION, INC. PAXSCAN4030D/SHFRM300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23360 DA