BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3874564 · Received April 22, 2014

    Report

    Report Number
    1720753-2014-03495
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 22, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE GPOS (GENERAL PURPOSE OPERATING SYSTEM) AND RTOS (REAL TIME OPERATING SYSTEM) BOARDS WERE EVALUATED AND REPLACED. THE SYSTEM SOFTWARE AND CALIBRATION FILES WERE RELOADED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE WORKSTATION MONITORS WENT BLACK DURING A PROCEDURE. THIS COULD CAUSE THE SYSTEM TO BECOME UNUSABLE DUE TO THE INABILITY TO DISPLAY A LIVE IMAGE. THERE IS NO REPORT OF INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243183 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1