BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6600

    MDR report key: 2101807 · Received May 10, 2011

    Report

    Report Number
    1720753-2011-07161
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 10, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE KEYBOARD, THE CONTROLLER, AND THE INTERFACE BOARD WERE REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN OPERATION, THE SYSTEM SHUT DOWN AND REQUIRED TWO ATTEMPTS TO REBOOT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6600

    Patients

    Seq Age Sex Outcome Treatment
    1