BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 3811094 · Received March 24, 2014

    Report

    Report Number
    1720753-2014-02657
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    December 16, 2013
    Report Date
    March 24, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE CUSTOMER CHOSE TO DE-INSTALL THE SYSTEM AND CHOSE NOT TO COMPLETE ANY FURTHER REPAIRS AT THIS TIME. 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 EXPERIENCED AN IMMEDIATE LOSS OF SYSTEM FUNCTIONALITY AND AN UN-COMMANDED SHUT DOWN. THERE IS NO REPORT OF A PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173401 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1