BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600+

    MDR report key: 1011848 · Received March 11, 2008

    Report

    Report Number
    1720753-2008-17898
    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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION AT THIS TIME. WHEN ADDITIONAL INFORMATION IS PROVIDED, IT WILL BE REPORTED AS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9600+ SYSTEM SMELLED LIKE SOMETHING WAS BURNING AND IT SHUT DOWN DURING A CASE. REBOOT WAS REQUIRED AND THE CASE WAS COMPLETED. 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 NI