BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IGS 530

    MDR report key: 3973025 · Received April 29, 2014

    Report

    Report Number
    9611343-2014-00065
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    IZI
    PMA / PMN Number
    K122457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER EMAIL WAS NOT PROVIDED. THIS MALFUNCTION WAS DETERMINED TO BE REPORTABLE AS THIS SAME MALFUNCTION HAS PREVIOUSLY CONTRIBUTED TO A SERIOUS INJURY WITHIN THE LAST THREE YEARS. REF MDR 9611343-2011-00001. THE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMAGES ON THE EXAM ROOM LIVE MONITOR WERE FLICKERING. THIS ISSUE MAY RESULT IN A DEGRADED IMAGE QUALITY THAT CAN PREVENT COMPLETION OF AN EXAM. NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255540 IGS 530 SYSTEM, X-RAY, ANGIOGRAPHIC IZI GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1