BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3870015 · Received April 28, 2014

    Report

    Report Number
    1720753-2014-03707
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    March 26, 2014
    Report Date
    April 28, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. ON SITE INVESTIGATION REVEALED THAT NO CAUSE COULD BE DETERMINED. THE RTOS (REAL TIME OPERATING SYSTEM) AND GPOS (GENERAL PURPOSE OPERATING SYSTEM) CPU PCB ASSEMBLIES WERE RESEATED DURING THE SERVICE EVENT. THE SYSTEM SOFTWARE WAS ALSO RELOADED. 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 SYSTEM WAS NOT FUNCTIONING PROPERLY. FURTHER INFORMATION WAS RECEIVED FROM THE FSE INDICATING THAT THE DEVICE FAILED TO PROPERLY SAVE AND RECALL PATIENT IMAGE DATA. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253767 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1