BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4942020 · Received July 21, 2015

    Report

    Report Number
    4942020
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    July 10, 2015
    Report Date
    July 21, 2015
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC
    Product Code
    OXO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CATHETERIZATION LAB C-ARM EQUIPMENT HAD A "GANTRY FAILURE, CALL SERVICE" ERROR MESSAGE WHEN STAFF ATTEMPTED TO READY THE ROOM FOR A PROCEDURE. BIO-MED WAS CALLED AND WERE ABLE TO GET EQUIPMENT OPERATIONAL. NO INJURY OR IMPACT TO PATIENT, EXCEPT A 45 MINUTE DELAY IN MOVING PROCEDURE TO AN ALTERNATE CATHETERIZATION LAB ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470815 * IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO GE OEC MEDICAL SYSTEMS, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR NO OTHER THERAPIES