BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2884819 · Received December 3, 2012

    Report

    Report Number
    1720753-2012-09933
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    October 19, 2012
    Report Date
    November 30, 2012
    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 SVC REP PERFORMED AN ON SITE INVESTIGATION. THE HARD DRIVE AND THE SOFTWARE UPGRADE WERE INSTALLED DURING THE SVC CALL. THE SYS WAS TESTED AND FOND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYS WAS HAVING ISSUES SAVING IMAGES. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1