BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 2960817 · Received January 30, 2013

    Report

    Report Number
    1720753-2013-01300
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYS AND REPLACED THE VIDEO CONTROLLER BOARD. THE SYS OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYS WOULD INTERMITTENTLY FAIL TO DISPLAY A VISIBLE FLUOROSCOPIC LIVE IMAGE. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41380 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1