BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FISCHER

    MDR report key: 101524 · Received June 13, 1997

    Report

    Report Number
    101524
    Event Type
    Injury
    Date Received
    June 13, 1997
    Date of Event
    September 19, 1996
    Report Date
    May 16, 1997
    Manufacturer
    FISCHER IMAGING CORP.
    Product Code
    IZO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    POSSIBLE RADIATION BURN TO PT'S RIGHT ARM IN LINE WITH LATERAL PLANE X-RAY TUBE'S BEAM AXIS DURING ABLATION (ELECTRO-PHYSIOLOGY) PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FISCHER BIPLANE FLUOROSCOPY/CINE SYSTEM IZO FISCHER IMAGING CORP. 55761G-2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention