BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 3823498 · Received February 19, 2014

    Report

    Report Number
    1720753-2014-01667
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 31, 2014
    Report Date
    February 19, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE BOARDS AND CONNECTORS WERE RESEATED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM EXPERIENCED AN IMMEDIATE LOSS OF SYSTEM FUNCTIONALITY AND AN UN-COMMANDED SHUT DOWN. THERE IS NO REPORT OF A PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105041 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1