BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1070867 · Received July 9, 2008

    Report

    Report Number
    1720753-2008-22832
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 24, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS 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

    DURING ACCEPTANCE TESTING, PHYSICIST BELIEVED HE FOUND A NON-LINEARITY ISSUE WITH DIGI-SPOT MODE. HE MADE AN ASSUMPTION THAT DIGI-SPOT WAS THE SAME AS FILM SHOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1