BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA 4100

    MDR report key: 2096942 · Received May 6, 2011

    Report

    Report Number
    9611343-2011-00042
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 7, 2011
    Report Date
    May 6, 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 YRS. 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 AND THE CONTROL ROOM MONITOR DURING FLUOROSCOPY. IT WAS REPORTED THAT THE IMAGE WAS UNUSABLE WHEN IT WAS FLICKERING. 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 F/U 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