BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 2973995 · Received February 19, 2013

    Report

    Report Number
    9680959-2013-00398
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 19, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE HARD DRIVE AND RELOADED SOFTWARE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WOULD NOT PRODUCT X-RAYS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72816 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1