BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3050828 · Received April 10, 2013

    Report

    Report Number
    1723170-2013-00272
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT PRESENT. WHEN THE REPRESENTATIVE OBSERVED THIS SUDDEN SHUT DOWN, HE CHECKED THE OUTPUT FROM THE UPS/TRANSFORMER AND FOUND THAT THERE WAS NO 120 V AC OUTPUT. HE ALSO CHECKED THE BATTERIES OUTPUT AND GOT 13.4 V DC FROM BOTH THE BATTERIES. IF THE BATTERIES HAD A CHARGE AND THE SWITCH ON THE BACK OF THE SYSTEM WAS NOT ENGAGED, THERE COULD BE AN ISSUE WITH THE POWER DISTRIBUTION COMING FROM THE UNINTERRUPTIBLE POWER SUPPLY (UPS). HOWEVER, AFTER THE REPORTED ISSUE THE MEDTRONIC REP TESTED THE SYSTEM ON SITE AND WAS NOT ABLE TO REPLICATE THE REPORTED EVENT. THEY HAVE DONE 10 SURGERIES WITH THIS SYSTEM AND THE ISSUE HAS NOT RECURRED. THE REP SUSPECTS THAT THERE WAS SOME SORT OF POWER FLUCTUATION WITH THE FACILITY, BUT WILL REPLACE THE UNINTERRUPTIBLE POWER SUPPLY (UPS) AS A PRECAUTION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SYSTEM HAD AN INTERMITTENT ISSUE RELATED TO LOSING POWER. HE INDICATED THAT THERE WAS NO ERROR OR MESSAGE WARNINGS ON THE SCREEN AND HE DID NOT HEAR ANY BEEPS TO ALERT HIM THE SYSTEM WAS SHUTTING DOWN. HE STATED THAT THE SYSTEM GOES OFF SUDDENLY WITH NO POWER TO THE SCREEN OR OTHER COMPONENTS OF THE SYSTEM. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153412 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1