BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA 4100

    MDR report key: 2086776 · Received April 4, 2011

    Report

    Report Number
    9611343-2011-00034
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 7, 2011
    Report Date
    April 4, 2011
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    MQB
    PMA / PMN Number
    K052412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM WAS ORIGINALLY CLEARED UNDER K023178; SYSTEM WAS UPGRADED IN 2006 WITH ENHANCED SOFTWARE OPTION CLEARED UNDER K052412. 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 INNOVA 4100 SYSTEM WAS EXPERIENCING A FLICKERING OF THE IMAGE ON THE LIVE MONITOR DURING FLUOROSCOPY. THE ISSUE MAY RESULT IN A DEGRADED IMAGE QUALITY THAT CAN PREVENT COMPLETION OF AN EXAM. NO PATIENT 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 INNOVA 4100 ANGIOGRAPHIC X-RAY SYSTEM MQB GE MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1