BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3964448 · Received June 19, 2014

    Report

    Report Number
    1720753-2014-05196
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 18, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE RUI WAS IN NEED OF REPLACEMENT. THE CUSTOMER REQUESTED FOR A QUOTE. THE QUOTE WAS PROVIDED TO THE CUSTOMER; HOWEVER, THE CUSTOMER HAS NOT RESPONDED BACK. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RUI OR REMOTE USER INTERFACE WAS NOT WORKING. THIS WOULD LEAD TO LOSS OF MOTORIZED MOVEMENTS. COMPLETE LOSS OF MOTORIZED FUNCTIONALITY MAY RESULT IN INABILITY TO OBTAIN IMAGES. THERE IS NO REPORT OF INJURY OR DEATH

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359154 9900 FLUOROSCOPE X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1