BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1820070 · Received August 23, 2010

    Report

    Report Number
    1720753-2010-02700
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    June 25, 2010
    Report Date
    August 23, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE CINE DISK AND THE SOFTWARE UPGRADE WERE INSTALLED DURING THE SERVICE CALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9800 SYSTEM HAD POOR IMAGE QUALITY ON THE SAVED IMAGES WITH STREAKS IN THE IMAGES. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1