BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600EMI

    MDR report key: 1070847 · Received July 9, 2008

    Report

    Report Number
    1720753-2008-22795
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 23, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN INTERCONNECT CABLE WAS MOVED, THEN IMAGE WAS LOST AGAIN. FOUND THAT THE VIDEO WIRE IN THE INTERCONNECT CABLE WAS BROKEN. THIS WAS VISIBLE WHEN LEMO CONNECTION WAS REMOVED FROM CABLE. THE REP REPLACED THE CABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT SYSTEM IMAGE WOULD NOT CHANGE ON THE MONITOR WHEN THEY ATTEMPTED TO MAKE AN IMAGE. THEN SYSTEM WAS REBOOTED AND FUNCTIONED NORMALLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1