BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASOUND SYSTEM

    MDR report key: 6106344 · Received November 16, 2016

    Report

    Report Number
    3009498591-2016-00616
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    October 21, 2016
    Report Date
    April 28, 2017
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYO
    PMA / PMN Number
    K142628
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    SERVICE PERSONNEL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO UPDATE THE DEVICE AVAILABLE FOR EVALUATION (SEE D10), UPDATE THE FOLLOW-UP TYPE (SEE H2), UPDATE THE DEVICE EVALUATED BY MANUFACTURER (SEE H3), UPDATE THE EVENT PROBLEM AND EVALUATION CODES (SEE H6), AND PROVIDE THE INVESTIGATION RESULTS. INVESTIGATION: THE ROOT CAUSE FOR THE SYSTEM FREEZING DURING PATIENT STUDY WAS INVESTIGATED. THE PRIMARY ISSUE WAS A POOR CONNECTION BETWEEN THE TRANSDUCER AND SYSTEM. THE CONNECTOR ON THE 8V3C TRANSDUCER HAD FOREIGN CONTAMINANT (E.G., SALIENE OR GEL) AND WAS MATING INTERMITTENT CONTACT WITH SYSTEM. THE CUSTOMER SERVICE ENGINEER CLEANED THE TRANSDUCER CONNECTOR, WHICH SOLVED THE ISSUE. THE SECONDARY ISSUE WAS THAT THE POOR CONNECTION CAUSED AN ERROR WHICH REQUIRED REBOOT RATHER THAN BEING A RECOVERABLE ERROR. THIS ISSUE OCCURS WHEN THE CONNECTION CHANGES RAPIDLY (SUCH AS WHEN THE CONNECTION IS POOR), RESUTING IN A RAPIDLY CHANGING PROBE ID. THIS CAN RESULT IN A MISMATCH IN PROBE IDS IN THE LAYERS OF SOFTWARE AS DIFFERENT PIECES OF THE SOFTWARE SEE DIFFERENT IDS AS THE ID CHANGES RAPIDLY. THE MISMATCH IN IDS IS FLAGGED AS AN ERROR. AS A FINAL SOLUTION, THE PRIMARY ISSUE WAS FIXED BY SERVICE; THE CUSTOMER SERVICE ENGINEER CLEANED THE TRANSDUCER CONNECTOR, AND THERE WERE NO OTHER ISSUES. THE SECONDARY ISSUE WAS RESOLVED IN A FUTURE SOFTWARE RELEASE OF THE SC2000 ULTRASOUND SYSTEM.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL EVENT INFORMATION (SEE SECTION B5), UPDATE THE BRAND NAME OF THE DEVICE (SEE SECTION D1), CORRECT THE DATE RECEIVED BY MANUFACTURER (SEE SECTION G4), PROVIDE THE PMA/510(K) NUMBER (SEE SECTION G5), UPDATE DEVICE EVALUATED BY MANUFACTURER (SEE SECTION H3), CORRECT/UPDATE THE EVENT PROBLEM AND EVALUATION CODES (SEE SECTION H6), AND PROVIDE ADDITIONAL MANUFACTURER NARRATIVE. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO SIEMENS FOR EVALUATION; THEREFORE, THE INVESTIGATION OF THE DEVICE COULD NOT BE PERFORMED AND THE CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT AT THE BEGINNING OF A HEART EXAM, THE SYSTEM PROMPTED A "ACQUISITION ERROR." THE TRANSDUCER WAS REPLACED WHICH DELAYED THE EXAM APPROXIMATELY 15 MINUTES TO COMPLETE. IT WAS FURTHER REPORTED THAT THE ERROR NOTED OCCURRED ON A TRANSDUCER THAT WAS NOT IN USE AT THE TIME BUT WAS CONNECTED TO THE SYSTEM. THE STAFF DETERMINED THAT THE PROBE THAT THEY WERE USING AT THE TIME THE REPORTED PHENOMENON WAS NOTED DID NOT CAUSE THE ERROR. THERE WAS NO NEED TO REPEAT THE SCANNING SINCE THE PHENOMENON OCCURRED AT THE START OF THE EXAM. THERE WAS NO PATIENT OR USER INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS ISSUE IS UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    SYSTEM LOCK UP WHILE THE Z6MS WAS CONNECTED. THE INVESTIGATION IS IN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757576 ULTRASOUND SYSTEM DIAGNOSTIC ULTRASOUND DEVICE IYO SIEMENS MEDICAL SOLUTIONS USA, INC. SC2000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown