BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600+

    MDR report key: 1021705 · Received March 19, 2008

    Report

    Report Number
    1720753-2008-19689
    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
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. REPLACED THE LEMO CONNECTOR. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SVC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERMITTENTLY, THE 9600+ SYSTEM WILL NOT BOOT UP. IT WAS NOTED THAT THERE WAS NO FLUORO. 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