BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4142873 · Received September 12, 2014

    Report

    Report Number
    1720753-2014-07854
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 12, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN INVESTIGATION. THE PS1 5 VDC POWER SUPPLY CONNECTORS WERE EVALUATED AND RESEATED. THE POWER SUPPLY VOLTAGE WAS OPTIMIZED TO SPECIFICATION. THE GENERAL PURPOSES OPERATING SYSTEM, REAL TIME OPERATING SYSTEM AND GENERATOR INTERFACE BOARD COIN BATTERIES WERE ALSO REPLACED DURING THE SERVICE EVENT. THE CMOS SETTINGS WERE ALSO RESET AND WORKSTATION FUSE WERE RESEATED. THE SYSTEM WAS FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A COMMUNICATION FAILURE ERROR MESSAGE. THIS ERROR RESULTED IN A TEMPORARY LOSS OF SYSTEM FUNCTIONALITY THAT WAS RECOVERED BY A SYSTEM REBOOT. THERE IS NO REPORT OF A PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565381 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1