BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1070317 · Received July 9, 2008

    Report

    Report Number
    1720753-2008-20567
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 10, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEM INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FLUORO NOT FUNCTIONING PROPERLY DURING ANGIOGRAPHY PROCEDURE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEM INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1