BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600+

    MDR report key: 1191307 · Received October 9, 2008

    Report

    Report Number
    1720753-2008-20047
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 25, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER CANCELLED THE SVC CALL. ACCORDING TO INFO PROVIDED, THE SYSTEM WAS REBOOTED AND THE SCREEN IS FUNCTIONAL. SVC CANCELLED BY CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MONITOR SCREEN ON THE 6900+ SYSTEM DOES NOT LIGHT UP. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600+ FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 9600+ NA

    Patients

    Seq Age Sex Outcome Treatment
    1