BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3963755 · Received May 7, 2014

    Report

    Report Number
    1720753-2014-04006
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    March 11, 2014
    Report Date
    May 7, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HIGH PRESSURE INJECTOR ON THE SYSTEM WAS EVALUATED AND RESEATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A FAST STOP ACTIVATED ERROR MESSAGE. THE FIELD ENGINEER NOTED THAT THIS OCCURRED AS A RESULT OF A SYSTEM MALFUNCTION. THIS ERROR WIL CAUSE THE SYSTEM TO LOCK UP AND HAVE TO BE REBOOTED. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274825 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1