BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 2100358 · Received May 13, 2011

    Report

    Report Number
    1720753-2011-07302
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 13, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION AND REPLACED THE IMAGE FUNCTION BOARD AND PERFORMED THE COLLIMATOR IRIS CALIBRATION. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SECOND FIELD OF THE SYSTEM WOULD NOT PROVIDE MAGNIFICATION OF IMAGE AND HIGH CONTRAST RESOLUTION ADJUSTMENT AND THAT THE RESOLUTION WAS BELOW LIMITS. THIS HAPPENED OUTSIDE OF A CASE. NO PATIENT 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