BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASOUND SYSTEM

    MDR report key: 6194263 · Received December 21, 2016

    Report

    Report Number
    3009498591-2016-00671
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    November 30, 2016
    Report Date
    April 28, 2017
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYN
    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 PROVIDE ADDITIONAL EVENT INFORMATION (SEE SECTION B5), UPDATE THE BRAND NAME OF THE DEVICE (SEE SECTION D1), PROVIDE INITIAL REPORTER CONTACT INFORMATION (SEE SECTION E1), UPDATE DEVICE EVALUATED BY MANUFACTURER (SEE SECTION H3), AND CORRECT THE RESULT CODE (SEE SECTION H6). 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.

    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 POSSIBLE ROOT CAUSE FOR THE VORTAL CRASH DURING EXAM WAS INVESTIGATED. THE LOGS INDICATE THAT PATIENT BROWSER WAS TRYING TO UPDATE THE VIEW FOR MORE THAN 100 STUDIES BEFORE THE CRASH. THERE IS A 2 MINUTE DELAY FOR THE BROWSER TO BE DEACTIVATED DUE TO SLOWNESS IN DATABASE OPERATIONS. THIS CAUSED THE TIMEOUT IN COMMUNICATION BETWEEN THE COMPONENTS, AND THE VORTAL CRASH. FURTHER ANALYSIS SHOWED THAT THIS IS A KNOWN SPORADIC ISSUE THAT IS ADDRESSED IN A NEW SOFTWARE RELEASE FOR THE SC2000 ULTRASOUND SYSTEM.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT DURING A HEART PROCEDURE, A VORTAL CRASH OCCURRED. THE USER REBOOTED THE SYSTEM TO CONTINUE AND COMPLETE THE PROCEDURE. THERE WAS NO NEED TO REPEAT THE PROCEDURE BECAUSE THERE WAS NO LOSS OF DATA. THERE WAS A 5 TO 10 MINUTES DELAY WHILE THE SYSTEM WAS REBOOTED. 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

    VORTAL CRASH DURING THE EXAM. THE INVESTIGATION IS IN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842682 ULTRASOUND SYSTEM DIAGNOSTIC ULTRASOUND DEVICE IYN SIEMENS MEDICAL SOLUTIONS USA, INC. SC2000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown