BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600EMI

    MDR report key: 1040801 · Received May 9, 2008

    Report

    Report Number
    1720753-2008-21393
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 8, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP RESEATED THE POWER CORD TO THE DICOM BOX, AND THE IMAGE DISPLAYED NORMALLY. SYSTEM OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT NO IMAGE BEING DISPLAYED ON LEFT MONITOR. ALSO, THE POWER TO DICOM BOX WAS DISCONNECTED.

    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