BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 1861178 · Received October 4, 2010

    Report

    Report Number
    1720753-2010-03337
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 15, 2010
    Report Date
    October 4, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE COLLIMATOR IRIS POTENTIOMETER, HARD DRIVE, AND CONTROL PANEL BOARD WERE INSTALLED DURING THE SVC CALL. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9600 SYS LOCKED UP WITH A COLLIMATOR IRIS POTENTIOMETER ERROR DURING A CASE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1