BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3980096 · Received June 5, 2014

    Report

    Report Number
    1720753-2014-04736
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 15, 2014
    Report Date
    June 5, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SYSTEMS INTERFACE PCB AND VIDEO CONTROLLER PCB WERE EVALUATED AND REPLACED. THE CMOS SETTINGS WERE ALSO RESET AND THE NODES WERE FLASHED DURING THE SERVICE EVENT. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED FRAME SYNC ERRORS AND FAILED TO ALLOW FLUOROSCOPIC EXPOSURES, EXHIBITING A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330381 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1