BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE HEALTHCARE INNOVA 3100

    MDR report key: 2439229 · Received February 2, 2012

    Report

    Report Number
    2439229
    Event Type
    Injury
    Date Received
    February 2, 2012
    Date of Event
    December 27, 2011
    Report Date
    January 27, 2012
    Manufacturer
    GE HEALTHCARE
    Product Code
    IZI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAS RADIATION BURN TO BACK FROM PROLONGED EXPOSURE DURING A CATH LAB PROCEDURE - FLUORO TIME WAS 139 MINUTES. ADDITIONAL INFORMATION ABOUT THE RADIATION DOSE IS NOT YET AVAILABLE - WILL SEND IN AN UPDATED REPORT ONCE WE RECEIVE THE DATA FROM GE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE HEALTHCARE INNOVA 3100 CARDIOLOGY SUITE/CATH LAB IZI GE HEALTHCARE 5314431-10

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other IMPLANTED:| BIVENTRICULAR PACEMAKER ICD