BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CX

    MDR report key: 274916 · Received April 20, 2000

    Report

    Report Number
    1418957-2000-00003
    Event Type
    Injury
    Date Received
    April 20, 2000
    Date of Event
    March 24, 2000
    Report Date
    April 20, 2000
    Manufacturer
    FISCHER IMAGING CORP.
    Product Code
    JAA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PULSE FLUORO QUIT WORKING, UNIT DID NOT ALARM OR SHUT OFF. EXTENSIVE TIME OF CASE RESULTED IN RADIATION BURN TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CX FLUOROSCOPIC SYSTEM JAA FISCHER IMAGING CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention