BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2182877 · Received July 11, 2011

    Report

    Report Number
    1720753-2011-08905
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 11, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE OUTPUT POWER SUPPLY VOLTAGE WAS ADJUSTED AND ALL THE CONNECTIONS WERE TIGHTENED. THE SOFTWARE AND THE CALIBRATION FILES WERE LOADED. 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 THE SYSTEM CORRUPTED THE INTEGRITY OF THE STORED FILES BY INTERMIXING DATA. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1