BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3060355 · Received April 11, 2013

    Report

    Report Number
    1720753-2013-04877
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 11, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE CUSTOMER INDICATED THE SYSTEM BEEPED AS IF THERE WAS LIVE FLUORO. THE SYSTEM DISPLAY MAY INDICATE THE SYSTEM IS ACTIVE WHEN, IN FACT, THE SYSTEM IS NOT PRODUCING LIVE X-RAYS. THE LEFT MONITOR OF THE SYSTEM WILL NOT UPDATE. THERE WILL BE NO RADIATION EMISSION OCCURRING DESPITE THE AUDIBLE AND VISUAL INDICATOR. IF THE VOLTAGE IS TOO LOW ON THE POWER SUPPLY, THE SECURITY LINE WILL BE DISCONNECTED AND THEREBY FAIL TO PRODUCE X-RAY. THE POWER SUPPLY WAS ADJUSTED 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 STOPPED WITH A COMMUNICATION ERROR AND CONTINUOUSLY BEEPED AS IF IT HAD LIVE FLUORO. A COMMUNICATION FAIL ERROR MESSAGE WILL LIKELY RESULT IN A SYSTEM LOCKUP, NO BOOT, OR SHUT DOWN SITUATION. THERE WAS NO PATIENT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156847 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1