BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3254305 · Received July 25, 2013

    Report

    Report Number
    1720753-2013-08584
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Date of Event
    July 12, 2013
    Report Date
    July 25, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE INTERCONNECT CABLE AND LEMO CONNECTOR WERE REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY DISPLAYED AN X-RAYS DISABLE MESSAGE. A SYSTEM REBOOT WAS REQUIRED IN ORDER TO REGAIN FUNCTIONALITY. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348270 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1