BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 3161654 · Received June 3, 2013

    Report

    Report Number
    9680959-2013-01070
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 4, 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

    A GE REP EVALUATED THE SYS AND RELOADED THE PC GUARD SOFTWARE. THE SYS OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYS ALARMED. THE FSE NOTED, "ALARM IS TRIGGERED. NO IMAGES. BLACK SCREEN IS DISPLAYED INTERMITTENTLY. "THE DESCRIPTION IS INDICATIVE OF A SYS LOCK UP. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242864 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1