BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON NX3 SERIES

    MDR report key: 6057292 · Received October 26, 2016

    Report

    Report Number
    3009498591-2016-00565
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    September 27, 2016
    Report Date
    October 26, 2016
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYN
    PMA / PMN Number
    K152469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    ALLEGED LOSS OF DATA. THE INVESTIGATION IS IN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709246 ACUSON NX3 SERIES DIAGNOSTIC ULTRASOUND DEVICE IYN SIEMENS MEDICAL SOLUTIONS USA, INC. NX3 SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1