BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 2202562 · Received August 5, 2011

    Report

    Report Number
    9680959-2011-01683
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 1, 2011
    Report Date
    August 5, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN OVER THE PHONE INVESTIGATION. TECHNICAL SUPPORT WAS PROVIDED TO THE CUSTOMER TO REPAIR THE VIDEO SYSTEM. THE CUSTOMER CANCELLED THE SERVICE CALL. THE REPORTED PROBLEM WAS RESOLVED BY THE CUSTOMER. NO ADDITIONAL SERVICE INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ADDITIONAL INFORMATION THAT THE SYSTEM'S VIDEO WAS NOT FUNCTIONING. NO PATIENT 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