BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3042629 · Received April 4, 2013

    Report

    Report Number
    1720753-2013-04641
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    December 6, 2012
    Report Date
    April 4, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP 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 IMAGES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138768 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1