BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3980033 · Received June 5, 2014

    Report

    Report Number
    1720753-2014-04721
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 15, 2014
    Report Date
    June 5, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. THE RTOS, GIB, INTERCONNECT CABLE AND PS1 POWER SUPPLY WERE EVALUATED AND REPLACED. THE VOLTAGE ON PS1 WAS READJUSTED. 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 INTERMITTENT COMMUNICATION FAILED ERROR MESSAGES. PER THE FSE, THE SYSTEM WAS REBOOTED AND THIS RESULTED IN A PROCEDURAL DELAY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330368 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1