BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3902564 · Received May 8, 2014

    Report

    Report Number
    1720753-2014-04044
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 8, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE BACKPLANE MOUNT, BACKPLANE, VIDEO CONTROLLER PCB, SYSTEM INTERFACE PCB, CPU PCB, DISPLAY ADAPTER PCB, IMAGE PROCESSOR PCB, PS1, FLUORO FUNCTION PCB, GIB PCB, INTERCONNECT CABLE AND HARD DRIVE WERE EVALUATED AND REPLACED. 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 FAILED TO BOOT TO A USABLE STATE AND EXHIBITED A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PT SERIOUS INJURY OR DEATH REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279952 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1