BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3060867 · Received April 5, 2013

    Report

    Report Number
    1720753-2013-04659
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 5, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE GENERATOR INTERFACE BOARD AND CINE HARD DRIVE WERE REPLACED AND THE SYSTEM SOFTWARE WAS RELOADED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE FIELD ENGINEER REPORTED THAT THE SYSTEM DISPLAYED THE MESSAGE "DATA ERROR AND SYSTEM ERROR DETECTED, X-RAYS ARE DISABLED" WHEN ATTEMPTING TO BOOT THE SYSTEM. THE ERROR MESSAGE COULD NOT BE CLEARED AND RENDERED THE SYSTEM UNUSABLE. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141932 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1