BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTX LCA

    MDR report key: 2092895 · Received April 11, 2011

    Report

    Report Number
    9611343-2011-00036
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    February 8, 2011
    Report Date
    April 11, 2011
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    IZI
    PMA / PMN Number
    K945375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT INCIDENT DATE IS UNK. IT IS BELIEVED THAT THE EVENT OCCURRED ON OR BEFORE (B)(6) 2011. THIS MALFUNCTION WAS DETERMINED TO BE REPORTABLE AS THIS SAME MALFUNCTION HAS PREVIOUSLY CONTRIBUTED TO A SERIOUS INJURY WITHIN THE LAST TWO YEARS. REFERENCE MDR 9611343-2011-00001.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ADVANTX SYSTEM WAS EXPERIENCING A FLICKERING OF THE IMAGE ON THE LIVE MONITOR OF THE EXAM ROOM. THE ISSUE MAY RESULT IN A DEGRADED IMAGE QUALITY THAT CAN PREVENT COMPLETION OF AN EXAM. NO PT INJURY OR DEATH REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTX LCA ANGIOGRAPHIC X-RAY SYSTEM IZI GE MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1