BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI C-ARM

    MDR report key: 8155095 · Received December 11, 2018

    Report

    Report Number
    MW5082041
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    November 15, 2018
    Report Date
    December 10, 2018
    Manufacturer
    ORTHOSCAN, INC.
    Product Code
    OXO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE MINI C-ARM WAS SETUP IN ROOM. BEFORE USE, IT ALARMED AND WE DISCOVERED THAT IT HAD GIVEN OFF FLUOROSCOPE / XRAY FOR A DURATION OF 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993637 MINI C-ARM IMAGE - INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM MOBILE OXO ORTHOSCAN, INC. B87343

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR