BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON SEQUOIA C512 CARDIOLOGY

    MDR report key: 6181699 · Received December 16, 2016

    Report

    Report Number
    3009498591-2016-00661
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 16, 2016
    Report Date
    February 2, 2017
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYN
    PMA / PMN Number
    K072365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. - A PROBLEM OCCURED WHEN THE CUSTOMER COMPLETED THE STUDY. HOWEVER, THE STUDY UTILITIES STUDY WAS GONE; THE STUDY WAS LOST ON THE SYSTEM. - DURING THE INVESTIGATION, THE INVESTIGATOR NOTED THAT A SOFTWARE RELOAD WAS PERFORMED TO FIX THIS ISSUE, AND LOG FILES WERE LOST. THEREFORE, THE INVESTIGATION FOR ROOT CAUSE WAS NOT POSSIBLE FOR THIS CASE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL EVENT INFORMATION (SEE SECTION B5), UPDATE DEVICE EVALUATED BY MANUFACTURER (SEE SECTION H3), CORRECT THE RESULTS CODE (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 AFTER AN ADULT ECHOCARDIOGRAPHY EXAM WAS COMPLETED, THE PATIENT'S STUDY WAS FOUND TO BE LOST. THE STUDY WAS REPORTED TO BE UNRECOVERABLE. THE PATIENT WAS REQUESTED TO RETURN TO BE RESCANNED. THERE WAS NO PATIENT OR USER INJURY REPORTED DURING THE INITIAL SCAN. 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

    AFTER THE CUSTOMER HAD COMPLETED THE STUDY, THE STUDY WAS GONE FROM THE STUDY UTILITIES. A SOFTWARE RELOAD WAS COMPLETED. THE INVESTIGATION IS IN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833022 ACUSON SEQUOIA C512 CARDIOLOGY DIAGNOSTIC ULTRASOUND DEVICE IYN SIEMENS MEDICAL SOLUTIONS USA, INC. SEQUOIA C512

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown