BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1317413 · Received February 20, 2009

    Report

    Report Number
    1720753-2008-27865
    Event Type
    Malfunction
    Date Received
    February 20, 2009
    Date of Event
    October 17, 2008
    Report Date
    November 6, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP STATED THE CAUSE OF THE PIXEL SHIFT WAS CAUSED BY A NAI DICOM BOX. THE NAI BOX REPLACEMENT WAS SHIPPED BY NAI. HE REPLACED THE MONITOR. THE SYSTEM WAS RETURNED TO FULL OPERATIONAL CAPACITY. THE REPLACEMENT NAI BOX WAS SENDING IMAGES TO THE PACS SERVER AND VERIFIED BY STAFF. THE SYSTEM OPERATES AS INTENDED. THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT NUMBER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LEFT MONITOR WAS PULSATING WITH FLASHING BRIGHTNESS AND THE RIGHT MONITOR WAS DIGITAL BREAK-UP WITH THE IMAGE BEING TORN AND HAVING A DIGITAL PIXEL SHIFT. THE SYSTEM WAS REMOVED FROM THE CASE AND A SECONDARY UNIT WAS BROUGHT IN. NO PATIENTS WERE INJURED AS A RESULT OF THIS SYSTEM FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1