BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2251398 · Received September 9, 2011

    Report

    Report Number
    1720753-2011-21791
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 23, 2011
    Report Date
    September 9, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC0
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REPRESENTATIVE REPLACED THE GENERATOR DRIVER BOARD. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A CHANNEL 15 ERROR MESSAGE AND WOULD NOT PERFORM FLUOROSCOPY. THIS HAPPENED DURING A CASE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC0 9800

    Patients

    Seq Age Sex Outcome Treatment
    1