BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3033122 · Received April 1, 2013

    Report

    Report Number
    1720753-2013-04438
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 1, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED A BLOWN FUSE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS DOUBLE EXPOSING, MAKING IT HARD TO READ THE IMAGES. THE ISSUE COULD CAUSE THE SYSTEM TO BECOME UNUSABLE DUE TO THE INABILITY TO VIEW THE LIVE FLUOROSCOPIC IMAGE. 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
    133121 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1