BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA 2100IQ

    MDR report key: 3973031 · Received April 29, 2014

    Report

    Report Number
    9611343-2014-00063
    Event Type
    Injury
    Date Received
    April 29, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K092004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO WAS NOT PROVIDED. INITIAL REPORTER EMAIL WAS NOT PROVIDED. THIS HIGH AIR-KERMA DOSE, NOT POSSIBLY REDUCED TO THE LOWEST BY USING DOES 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. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT RECEIVED A HIGH DOSE AROUND 15 GY, WHILE BEING SCANNED WITH AN INNOVA 2100IQ. THERE WAS NO SYSTEM FAILURE OR MALFUNCTION, AND NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255541 INNOVA 2100IQ FLUOROSCOPIC X-RAY SYSTEM OWB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other