BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 3102188 · Received May 3, 2013

    Report

    Report Number
    1720753-2013-05684
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 3, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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

    IT WAS REPORTED THAT THE SYSTEM PRODUCED UNCOMMANDED X-RAYS. THERE IS NO REPORT OF PATIENT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195108 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1