BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600+

    MDR report key: 1021708 · Received March 19, 2008

    Report

    Report Number
    1720753-2008-19693
    Event Type
    Malfunction
    Date Received
    March 19, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 17, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. IDENTIFIED THE NEED TO DISCONNECT THE JAZ DRIVE. THE JAZ DRIVE WAS DISCONNECTED. ONCE DISCONNECTED, THE SYSTEM WORKED AS INTENDED. NO ADD'L INFORMATION AT THIS TIME. IF ADD'L INFO IS RECEIVED A FOLLOW-UP REPORT WILL BE FILED AS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9600+ SYSTEM WILL NOT BOOT UP. IT WAS NOTED THAT THE SYSTEM STOPS AT A1. 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