BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 2152928 · Received June 17, 2011

    Report

    Report Number
    1720753-2011-08264
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 17, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE BIOS WAS RESET, THE HARD DRIVE WAS REFORMATTED AND THE SOFTWARE WAS RELOADED. THE HARD DRIVE AND THE KEYBOARD WERE REPLACED. THE SERVICE NODES WERE REBUILT AND THE CALIBRATION FILES WERE RELOADED. THE ALARM SPEAKER, THE RIBBON CABLES, THE HAND CONTROL AND THE FOOT PEDAL WERE REPLACED AND THE POWER SUPPLY WAS ADJUSTED. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT PRODUCE X-RAYS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1