BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3161659 · Received June 3, 2013

    Report

    Report Number
    1720753-2013-06742
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 4, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYS AND RESEATED THE FLUORO FUNCTIONS BOARD AND THE ASSOCIATED CABLES AND CONNECTORS. THE SYS OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYS DISPLAYED A COMMUNICATION ERROR. THIS ERROR WILL CAUSE THE SYS TO LOCKUP, SHUT DOWN, OR NOT TO BOOT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242584 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1