BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3111909 · Received May 7, 2013

    Report

    Report Number
    1720753-2013-05750
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 7, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE BOARDS WERE RESEATED, THE HIGH VOLTAGE TANK WAS REPLACED, AND THE FILAMENT WAS CALIBRATED 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 CINE MODE WAS NOT WORKING AND THE SYSTEM DISPLAYED AN OVERLOAD FAULT. THIS ERROR MAY CAUSE THE SYSTEM TO SHUT DOWN. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199933 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1