BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 2210353 · Received August 8, 2011

    Report

    Report Number
    9680959-2011-01684
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 26, 2011
    Report Date
    August 8, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE X-RAY TUBE NEEDED TO BE REPLACED. IT IS ANTICIPATED THAT FOLLOWING THIS REPAIR, THE SYSTEM WILL BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A GENERATOR ERROR MESSAGE AND WOULD NOT PERFORM FLUOROSCOPIC X-RAY. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1