BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600+

    MDR report key: 1061673 · Received August 27, 2007

    Report

    Report Number
    1720753-2007-04752
    Event Type
    Malfunction
    Date Received
    August 27, 2007
    Date of Event
    August 7, 2007
    Report Date
    August 27, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN EVAL OVER THE TELEPHONE. THE MALFUNCTION COULD NOT BE VERIFIED. 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 SYSTEM 9600+ LOCKED UP AFTER SUCCESSFULLY INITIALIZING. THE SYSTEM WAS PULLED AND A REPLACEMENT SYSTEM USED. THERE WAS NO ADVERSE PT INVOLVEMENT REPORTED. THERE WAS NO PT INFO REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1