BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA 3100

    MDR report key: 4162844 · Received October 8, 2014

    Report

    Report Number
    9611343-2014-00070
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 9, 2014
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K052412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS TESTED BY THE PHYSICIST AND DETERMINED TO OPERATE WITHIN ALL NORMAL PARAMETERS, POST PROCEDURE. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THIS HIGH AIR-KERMA DOES, NOT POSSIBLY REDUCED TO THE LOWEST BY USING DOSE REDUCTION FEATURES PROVIDED BY THE SYSTEM, IS LIKELY TO RESULT IN A SERIOUS INJURY SINCE IT MAY TAKE SOME TIME BEFORE HAVING ANY RADIATION BURN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED A HIGH DOSE ABOVE 15 GY, WHILE BEING SCANNED WITH AN INNOVA 3100. THERE WAS NO REPORT OF DEVICE MALFUNCTION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631338 INNOVA 3100 INTERVENTIONAL FLUOROSCOPIC X-RAY SY OWB GE MEDICAL SYSTEMS SCS XCA319

    Patients

    Seq Age Sex Outcome Treatment
    1 Other