BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 3192188 · Received June 20, 2013

    Report

    Report Number
    1720753-2013-07428
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 20, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE HARD DRIVE AND RELOADED SOFTWARE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM MIXED UP AND LOST IMAGES. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279603 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1