BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1930066 · Received December 2, 2010

    Report

    Report Number
    9617766-2010-00806
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    October 4, 2010
    Report Date
    December 1, 2010
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE HARD DRIVE, DISK CONTROLLER BOARD, CPU BATTERY, AND RELOADED SOFTWARE. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, THE SYSTEM WILL NOT COMPLETE BOOT UP. 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