BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3113246 · Received May 8, 2013

    Report

    Report Number
    1720753-2013-05839
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 8, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE SRAM AND THE SOFTWARE UPGRADE WERE INSTALLED DURING THE SVC CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SVC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYS S-RAM WAS NOT COMMUNICATING WITH TECHNIQUE PROCESSOR. THIS ISSUE MAY PREVENT THE SYS FROM PRODUCING A FLUOROSCOPIC IMAGE AND CAUSE THE SYS TO BECOME UNUSABLE. THERE WAS NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202434 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1