BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA 2000

    MDR report key: 1289444 · Received January 13, 2009

    Report

    Report Number
    9611343-2009-00002
    Event Type
    Injury
    Date Received
    January 13, 2009
    Date of Event
    November 28, 2006
    Report Date
    January 13, 2009
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    IZI
    PMA / PMN Number
    K024200
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT RECEIVED A RADIATION BURN DUE TO AN EXPOSURE TO AN ALLEGED LARGE DOSE OF RADIATION DURING AN ELECTROPHYSIOLOGY EXAM. THE EXTENT OF THE BURN IS UNK AT THIS TIME. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 2000 VASCULAR X-RAY SYSTEM IZI GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other