BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3791875 · Received January 3, 2014

    Report

    Report Number
    1720753-2014-00099
    Event Type
    Malfunction
    Date Received
    January 3, 2014
    Date of Event
    December 17, 2013
    Report Date
    January 3, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND EVALUATED AND REPLACED THE RTOS AND RELOADED THE NODES BUT NO CONCLUSION CAN BE DRAWN AS FURTHER REPAIR INFO IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A COMMUNICATION FAILURE ERROR MESSAGE. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. THERE IS NOT REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5184 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1