BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3101690 · Received April 30, 2013

    Report

    Report Number
    1720753-2013-05478
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE X-RAY CONTROLLER BOARD WAS REPLACED AND THE SYSTEM SOFTWARE WAS RELOADED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT UP. THERE IS NO REPORT OF PT INJURY ASSOCIATED THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188005 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1