BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 2934668 · Received January 4, 2013

    Report

    Report Number
    9680959-2013-00040
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 4, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE MONOBLOCK TUBE ASSEMBLY AND THE COLLIMATOR. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A GENERATOR ERROR AND STOPPED WORKING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5813 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1