BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA 2100-IQ

    MDR report key: 2856575 · Received December 3, 2012

    Report

    Report Number
    9611343-2012-00043
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    MQB
    PMA / PMN Number
    K050489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMAGES ON THE EXAM ROOM LIVE MONITOR WERE FLICKERING AND WAS NOT USABLE BY THE DOCTORS. THIS ISSUE MAY RESULT IN A DEGRADED IMAGE QUALITY THT CAN PREVENT COMPLETION OF AN EXAM. THERE WAS NO REPORTED PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 2100-IQ FLUOROSCOPIC X-RAY SYSTEM MQB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1