BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 1011838 · Received March 11, 2008

    Report

    Report Number
    1720753-2008-17888
    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
    NJ, 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. ADJUSTED THE CAMERA FOCUS AND KV TRACKING. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SVC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING QA TESTING OF THE 9600 SYS THE IMAGE QUAL WAS NOT AS GOOD AS EXPECTED. 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