BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 3113232 · Received May 8, 2013

    Report

    Report Number
    1720753-2013-05842
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 8, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE DISPLAY ADAPTOR BOAR WAS REPLACED DURING THE SVC CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SVC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT BOTH OF THE MONITORS DISPLAYED LINES AND UNUSABLE IMAGES. THIS ISSUE WOULD PREVENT THE LIVE IMAGE FROM BEING VIEWED AND RESULT IN A LOSS OF SYS FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202385 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1