BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 3871818 · Received April 17, 2014

    Report

    Report Number
    9680959-2014-00539
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 17, 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 REP PERFORMED AN ONSITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. THE C-ARM AND WORKSTATION CONNECTOR CABLE WAS REPLACED DURING SERVICE. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGES WERE VERY DARK AND UNUSABLE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235993 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1