BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 1030927 · Received April 17, 2008

    Report

    Report Number
    1720753-2008-20673
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 31, 2008
    Report Date
    April 15, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE SINGLE BOARD COMPUTER, IMAGE PROCESSOR, GENERATOR INTERFACE, SYS INTERFACE, AND CINE HARD DRIVE WERE REPLACED DURING THE SERVICE CALL. THE SYS WAS TESTED, AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CINE DRIVE ON THE 9800 SYS WOULD NOT WORK. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1