BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 3172181 · Received June 5, 2013

    Report

    Report Number
    9680959-2013-01080
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 5, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE HAND SWITCH. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM PRODUCED UNCOMMANDED X-RAYS. THERE IS NO REPORT OF PT INJURY OR DEATH. THERE WERE NO PT PRESENT DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249157 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1