BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600+

    MDR report key: 1000855 · Received February 21, 2008

    Report

    Report Number
    1720753-2008-16280
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 20, 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

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. PERFORMED A FILAMENT CALIBRATION. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9600+ SYSTEM PRESENTED A MA TOO HIGH ERROR ON THE C-ARM. 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 UNK