BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 3014239 · Received March 6, 2013

    Report

    Report Number
    1720753-2013-03485
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 6, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    THE CUSTOMER REPORTED THE SYSTEM LOST SAVED IMAGES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96502 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1