BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3791990 · Received January 14, 2014

    Report

    Report Number
    1720753-2014-00496
    Event Type
    Malfunction
    Date Received
    January 14, 2014
    Date of Event
    January 2, 2014
    Report Date
    January 14, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE FSE REMOVED AND RESEATED THE FFB PCB ASSEMBLY, IMAGE PROCESSOR PCB AND DISPLAY ADAPTER PCB. THE II POWER SUPPLY WAS ALSO EVALUATED AND WAS TO BE REPLACED ON SITE BY THE FACILITY. THE SYSTEM WAS WORKING PROPERLY UPON DEPARTURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A USABLE FLUOROSCOPIC IMAGE WAS UNABLE TO BE VIEWED. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36074 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1