BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600+

    MDR report key: 2954135 · Received November 20, 2007

    Report

    Report Number
    1720753-2007-08909
    Event Type
    Malfunction
    Date Received
    November 20, 2007
    Date of Event
    October 22, 2007
    Report Date
    November 19, 2004
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. REPLACED THE TEMPERATURE SENSOR. ALSO IDENTIFIED THE NEED TO CLEAN THE IMAGE INTENSIFIER FACE. CLEANING COMPLETED. 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 EXPERIENCED A X-RAY TEMP SENSOR FAILURE ERROR ON BOOT UP. 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