BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2101838 · Received May 10, 2011

    Report

    Report Number
    1720753-2011-07164
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 20, 2011
    Report Date
    May 10, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE GENERATOR CABLE HEADS AND THE X-RAY TUBE WERE CHECKED AND CLEANED. THE DEFECTIVE FANS 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 DURING FLUOROSCOPY THE SYSTEM PRODUCED A NOISE, "LIKE STRIKES", THE IMAGE WAS OUT OF FOCUS, AND AFTER RELEASING THE FLUOROSCOPY KEY THE SYSTEM CONTINUED TO EMIT X-RAYS. NO PATIENT INJURY WAS REPORTED.

    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