BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3162176 · Received June 3, 2013

    Report

    Report Number
    1720753-2013-06666
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 3, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE PS1 POWER SUPPLY, SURGE SUPPRESSOR AND FILAMENT DRIVER BOARDS WERE REPLACED, AND THE HIGH VOLTAGE CABLE CONNECTORS WERE REGREASED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WAS DISPLAYING INTERMITTENT LOW MA AND HIGH MA (MILLIAMPS) ERROR MESSAGES DURING A PT PROCEDURE. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242430 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1