BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3190084 · Received June 18, 2013

    Report

    Report Number
    1720753-2013-07328
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 19, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND RESEATED CIRCUIT BOARDS, CABLES, AND CONNECTORS. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEMS LEFT (LIVE) MONITOR WAS NOT TURNING ON. THIS CAN 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
    275970 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1