BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON SEQUOIA C512

    MDR report key: 6152782 · Received December 7, 2016

    Report

    Report Number
    3009498591-2016-00648
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    November 10, 2016
    Report Date
    December 7, 2016
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYN
    PMA / PMN Number
    K072365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    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

    STUDY WAS LOST WHEN THE SYSTEM SHOWED AN AEGIS ERROR. THE INVESTIGATION IS IN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803298 ACUSON SEQUOIA C512 DIAGNOSTIC ULTRASOUND DEVICE IYN SIEMENS MEDICAL SOLUTIONS USA, INC. SEQUOIA C512

    Patients

    Seq Age Sex Outcome Treatment
    1