BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2914944 · Received December 20, 2012

    Report

    Report Number
    1720753-2012-10713
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 10, 2012
    Report Date
    December 20, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WAS UNABLE TO MAKE FLUOROSCOPIC EXPOSURES. THE FSE NOTED THIS AS AN INTERMITTENT NO X-RAY ISSUE. THERE IS NO REPORT OF PATIENT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1