BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 3832687 · Received March 27, 2014

    Report

    Report Number
    9680959-2014-00417
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 27, 2014
    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

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SYSTEM DISPLAYED AN IMAGE FAILED TO BE SYNCHRONIZED ERROR. IT IS LIKELY THIS SYSTEM FAILED TO DISPLAY INTERPRETABLE IMAGES. THERE ARE NO REPORTS OF PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179347 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1