BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 2172181 · Received June 15, 2011

    Report

    Report Number
    9680959-2011-01443
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 15, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN OVER THE PHONE INVESTIGATION. TECHNICAL SUPPORT WAS PROVIDED TO THE CUSTOMER HOWEVER NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE AND NO ADDITIONAL SERVICE INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED AN ES8K ERROR MESSAGE AND THE WORKSTATION WOULD NOT BOOT UP. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1