BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1961232 · Received January 11, 2011

    Report

    Report Number
    9617766-2011-00059
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 11, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REFORMATTED THE HARD DRIVE AND RELOADED SOFTWARE. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM IS MIXING UP PT NAMES AND IMAGES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD 8800

    Patients

    Seq Age Sex Outcome Treatment
    1