BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA 2000

    MDR report key: 2974229 · Received February 19, 2013

    Report

    Report Number
    9611343-2013-00006
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    JAA
    PMA / PMN Number
    K022322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THIS MALFUNCTION WAS DETERMINED TO BE REPORTABLE AS THIS SAME MALFUNCTION HAS PREVIOUSLY CONTRIBUTED TO A SERIOUS INJURY WITHIN THE LAST TWO YEARS. REF MDR 9611343-2011-00001.

    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
    72813 INNOVA 2000 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIG) JAA GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1