BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3010952 · Received March 14, 2013

    Report

    Report Number
    1720753-2013-03779
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 22, 2013
    Report Date
    March 14, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE X-RAY CONTROLLER BOARD AND PERFORMED A FILAMENT CALIBRATION. THE SYS OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYS DISPLAYED AN ERROR AND LOCKED UP. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108322 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1