BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1890919 · Received October 28, 2010

    Report

    Report Number
    9617766-2010-00684
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 28, 2010
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYS AND REPLACED THE HARD DRIVE AND RELOADED SOFTWARE. SYS OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE DATE IS NOT BEING ANNOTATED ON IMAGES AND THAT IMAGES ARE BEING SAVED IN THE WRONG FOLDERS. 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