BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2192888 · Received July 25, 2011

    Report

    Report Number
    1720753-2011-20345
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 25, 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 REP PERFORMED AN ONSITE INVESTIGATION. THE SYSTEM HARD DRIVE WAS FORMATTED AND SOFTWARE WAS RELOADED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED MIXED AND MISMATCHED PT DATA. THERE WAS NO REPORT OF A PT INJURY.

    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