BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE INNOVA 3100

    MDR report key: 6098853 · Received November 14, 2016

    Report

    Report Number
    6098853
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 27, 2016
    Report Date
    November 8, 2016
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GE INNOVA X-RAY WENT DOWN DURING PROCEDURE. NO HARM TO PATIENT. THE PATIENT WAS MOVED TO ANOTHER ROOM AND THE PROCEDURE WAS COMPLETED. DURING THE PROCEDURE, THE SYSTEM WOULD LOCK UP AND NOT MAKE EXPOSURES. WHEN STAFF WOULD RE-BOOT THE SYSTEM, IT WOULD SHUT ITSELF OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751339 GE INNOVA 3100 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM IZI GE MEDICAL SYSTEMS, LLC 3100

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR