BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3162124 · Received June 6, 2013

    Report

    Report Number
    1720753-2013-06817
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 20, 2013
    Report Date
    June 6, 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 SVC REP PERFORMED AN ONSITE INVESTIGATION. THE FLUORO FUNCTIONS BOARD WAS REPLACED, THE PS1 POWER SUPPLY CONNECTORS WERE CLEANED AND RESEATED, AND THE SYS SOFTWARE WAS RELOADED. THE SYS WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYS DISPLAYED INTERMITTENT X-RAY DISABLED ERROR MESSAGES AT BOOT UP. THIS ERROR MESSAGES WILL PREVENT THE SYS FROM PRODUCING X-RAYS. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250614 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1