BEUDAMED
    FDA Adverse Event Other Summary report: N

    INNOVA 3100-IQ

    MDR report key: 3593357 · Received January 3, 2014

    Report

    Report Number
    9611343-2014-00001
    Event Type
    Other
    Date Received
    January 3, 2014
    Date of Event
    December 4, 2013
    Report Date
    December 5, 2013
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K052412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO WAS NOT PROVIDED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT REC'D A PEAK DOSE AROUND 12 GY AT IRP (INTERVENTIONAL REFERENCE POINT) IN THE SAME BODY AREA, WHILE BEING SCANNED WITH AN INNOVA 3100-IQ SYSTEM. THERE WAS NO SYSTEM FAILURE OR MALFUNCTION AND NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4773 INNOVA 3100-IQ INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1