BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2903365 · Received December 14, 2012

    Report

    Report Number
    1720753-2012-10473
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 14, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE CONTROL PANEL PROCESSOR CIRCUIT BOARD WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A COMMUNICATIONS FAIL AND CONTROL PANEL PROCESSOR ERROR MESSAGE. THESE MESSAGES WILL LIKELY RESULT IN A SYSTEM SHUT DOWN SITUATION AND/OR LOCK UP DEPENDING ON WHEN THE ERROR MESSAGE OCCURRED. THERE IS NO REPORT OF PATIENT INJURY.

    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