BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2153505 · Received June 21, 2011

    Report

    Report Number
    1720753-2011-08364
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 21, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REPRESENTATIVE CONDUCTED AN ONSITE INVESTIGATION. THE INTERCONNECT CABLE WAS REPLACED. THE NODES WERE FLASHED AND RELOADED. THE SOFTWARE AND CONFIGURATION FILES WERE RELOADED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1