BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3802183 · Received December 30, 2013

    Report

    Report Number
    1720753-2013-13840
    Event Type
    Malfunction
    Date Received
    December 30, 2013
    Date of Event
    November 5, 2013
    Report Date
    December 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS SLC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SYSTEM SOFTWARE AND CALIBRATIONS WERE EVALUATED AND RELOADED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INTERMITTENT LOSS OF VASCULAR IMAGING MODE FUNCTIONALITY. NO PATIENT OR USER INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679397 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS SLC 9900

    Patients

    Seq Age Sex Outcome Treatment
    1