BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 2092785 · Received May 5, 2011

    Report

    Report Number
    1720753-2011-06976
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 15, 2011
    Report Date
    May 5, 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 POWER BOARD VOLTAGE WAS REGULATED, THE GENERATOR CHECKED AND THE CONNECTORS WERE CLEANED. 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 MONITOR OF THE SYSTEM WAS OFTEN COMPLETELY BLACK. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1