BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7600

    MDR report key: 3042530 · Received April 2, 2013

    Report

    Report Number
    9680959-2013-00704
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 15, 2013
    Report Date
    April 2, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE MONITOR. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WOULD NOT DISPLAY AN IMAGE ON THE LEFT MONITOR. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134391 7600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7600

    Patients

    Seq Age Sex Outcome Treatment
    1