BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3791746 · Received January 21, 2014

    Report

    Report Number
    1720753-2014-00709
    Event Type
    Malfunction
    Date Received
    January 21, 2014
    Date of Event
    December 30, 2013
    Report Date
    January 21, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SYSTEM WAS DETERMINED TO REQUIRE FMI 15059 PRIOR TO COMPLETION OF FURTHER SYSTEM REPAIR. NO CONCLUSION CAN BE DRAWN AS CONCLUSIVE REPAIR INFO IS UNAVAILABLE AT THIS TIME AND NO ADDITIONAL SERVICE INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM FAILED TO PROPERLY SAVE AND RECALL PT IMAGE DATA. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50935 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1