BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2900803 · Received December 12, 2012

    Report

    Report Number
    1720753-2012-10381
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 22, 2012
    Report Date
    December 12, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WAS "NOT SHOOTING." THE FSE NOTED, "THE EQUIPMENT DOES NOT WORK," LOSS OF SYSTEM FUNCTIONALITY. THERE IS NO REPORT OF PT INJURY OR DEATH.

    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