BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3050699 · Received April 10, 2013

    Report

    Report Number
    1723170-2013-00269
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION. LOG FILES HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    AFTER FURTHER INVESTIGATION IT COULD NOT BE CONFIRMED THAT THE LOG DATA WAS RELATED TO THE REPORTED EVENT. UNABLE TO DETERMINE ROOT CAUSE WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    THE SOFTWARE INVESTIGATION CONFIRMED THE REPORTED EVENT. LOG FILES SHOWED THAT THE IPCVIDEOSOURCE WAS MOST LIKELY EXHIBITING AN INABILITY TO PROPERLY HANDLE NEW IMAGE DATA. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE STEALTHSTATION S7 SYSTEM LOGGED OUT WITHOUT WARNING DURING DEMONSTRATION OF ULTRASOUND NAVIGATION INTERFACE. NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148982 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1