BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7600

    MDR report key: 1011859 · Received March 11, 2008

    Report

    Report Number
    9680959-2008-00040
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 7, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE FILED WHEN ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING A PM INSPECTION OF THE 7600 SYSTEM, A PROBLEM WAS IDENTIFIED WITH THE IMAGE RESOLUTION. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 7600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1