BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 4203061 · Received September 18, 2014

    Report

    Report Number
    1720753-2014-07994
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 18, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. ONSITE INVESTIGATION INCLUDED EVALUATION OF THE INTERCONNECT CABLE, HOWEVER NO COMPONENTS WERE REPLACED. 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 INTERMITTENTLY FAILED TO ALLOW FLUOROSCOPIC EXPOSURES AND EXHIBITED INTERMITTENTLY FUNCTIONALITY. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578788 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1