BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 2941141 · Received January 18, 2013

    Report

    Report Number
    1720753-2013-00842
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 18, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE SINGLE BOARD COMPUTER AND ADJUSTED THE BRIGHTNESS AND CONTRAST CONFIGURATION SETTINGS. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGES WERE WHITE. THIS WILL CAUSE THE SYSTEM TO BE UNUSABLE DUE TO THE INABILITY TO SEE THE LIVE IMAGE. THERE IS NO REPORT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28256 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1