BEUDAMED
    FDA Adverse Event Other Summary report: N

    INNOVA 2100-IQ

    MDR report key: 3530203 · Received November 27, 2013

    Report

    Report Number
    9611343-2013-00034
    Event Type
    Other
    Date Received
    November 27, 2013
    Date of Event
    September 2, 2013
    Report Date
    September 2, 2013
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K052412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO WAS NOT PROVIDED. 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 SIGNIFICANT DOSE, AROUND 12 GY, IN THE SAME BODY AREA DURING AN EXAM WITH AN INNOVA 2100-IQ SYSTEM. THE TOTAL DOSE RECEIVED BY THE PT WAS AROUND 14 GY. THERE WAS NO SYSTEM FAILURE OR MALFUNCTION AND NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619433 INNOVA 2100-IQ INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1