BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 1013906 · Received March 18, 2008

    Report

    Report Number
    1720753-2008-16242
    Event Type
    Malfunction
    Date Received
    March 18, 2008
    Date of Event
    January 24, 2008
    Report Date
    February 19, 2008
    Manufacturer
    GE HEALTHCARE SURGERY
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE INVESTIGATED THE ISSUE AND FOUND A DAMAGED REMOTE USER INTERFACE THAT WAS REPLACED. WHILE ON SITE, THE SYSTEM DISPLAYED A LOW MA ERROR AND THE CALIBRATION FILES WERE RELOADED TO RESTORE FUNCTION. THE SYSTEM WAS TESTED, FOUND TO BE OPERATING AS INTENDED, AND RELEASED TO THE CUSTOMER FOR USE. NO PATIENT INJURY WAS REPORTED AS RESULT OF THIS COMPLAINT. THE FACILITY WAS UNABLE TO, OR REFUSED TO PROVIDE ANY FURTHER PATIENT INFORMATION WITH RESPECT TO THIS ISSUE.

    Description of Event or Problem · 1

    RUI JOYSTICK EMERGENCY STOP BUTTON MISSING. REMOTE USER INTERFACE (RUI) PROVIDES REMOTE C-ARM MECHANICAL MOVEMENTS. THE EMERGENCY STOP BUTTON WAS DAMAGED OR DESTROYED AND WOULD NOT BE AVAILABLE FOR USE IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9800 OEC 9800 MD JAA GE HEALTHCARE SURGERY NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1