BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 2844500 · Received November 5, 2012

    Report

    Report Number
    9680959-2012-01465
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 23, 2012
    Report Date
    November 5, 2012
    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 REPRESENTATIVE EVALUATED THE SYSTEM AND COULD NOT REPRODUCE THE REPORTED PROBLEM. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ISSUE WITH A FLUOROSCOPY FAULT. THE FSE NOTED, "THE SCREEN TURNS BLACK AND THE SYSTEM HAS TO BE REBOOTED." THIS DESCRIPTION IS INDICATIVE OF A SYSTEM LOCK-UP. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1