BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON SC2000 ULTRASOUND SYSTEM

    MDR report key: 6049398 · Received October 21, 2016

    Report

    Report Number
    3009498591-2016-00480
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    August 19, 2016
    Report Date
    October 21, 2016
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYN
    PMA / PMN Number
    K142628
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS UNDERGOING AN EVALUATION, BUT HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    AS A RESULT OF A RECENT FDA INSPECTION, WE ARE RETROSPECTIVELY REVIEWING COMPLAINTS AND ASSOCIATED DOCUMENTS FOR COMPLIANCE TO THE REGULATIONS FROM 2015 TO DATE. WE HAVE STRENGTHENED OUR MDR REPORTING CRITERIA AND WE ARE REPORTING THE ATTACHED MEDICAL DEVICE REPORT IN ACCORDANCE WITH OUR NEW CRITERIA. AS A RESULT OF THIS RETROSPECTIVE REVIEW, THIS MDR IS BEING REPORTED IMMEDIATELY UPON DISCOVERY. TAVR STUDY ON THE HARD DRIVE NOT ON PACS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699063 ACUSON SC2000 ULTRASOUND SYSTEM DIAGNOSTIC ULTRASOUND DEVICE IYN SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON S2000

    Patients

    Seq Age Sex Outcome Treatment
    1