BEUDAMED
    FDA Adverse Event Other Summary report: N

    GE OEC 9900

    MDR report key: 791703 · Received November 20, 2006

    Report

    Report Number
    1720753-2006-00188
    Event Type
    Other
    Date Received
    November 20, 2006
    Date of Event
    October 25, 2006
    Report Date
    November 20, 2006
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PREFORMED AN ON SITE INVESTIGATION. THE CIRCUIT BOARDS WERE REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS DISCOVERED THAT A 9900 SYSTEM WAS SHIPPED TO A CUSTOMER WITH UNVALIDATED PRINTED CIRCUIT BOARDS. THE SYSTEM WAS PART OF AN ENGINEERING VALIDATION OF A NEW CIRCUIT BOARD VENDOR. RIGHT SYSTEMS WERE BUILT AND THE ONE SYSTEM WAS INADVERTENTLY SHIPPED THE A CUSTOMER. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *