BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3960148 · Received June 24, 2014

    Report

    Report Number
    1720753-2014-05363
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 23, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE GENERAL PURPOSE OPERATING SYS (GPOS) AND THE SOFTWARE WERE INSTALLED 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 THAT THE SYSTEM WOULD NOT SAVE AN IMAGE AND THEN THE SYSTEM LOCKED UP. THIS CAUSED AN INTERMITTENT, RECOVERABLE LOSS OF IMAGING FUNCTIONALITY. THERE WAS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367185 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9900

    Patients

    Seq Age Sex Outcome Treatment
    1