BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACUSON

    MDR report key: 3142273 · Received May 23, 2013

    Report

    Report Number
    3009498591-2013-00003
    Event Type
    Other
    Date Received
    May 23, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 23, 2013
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA INC.
    Product Code
    IYN
    PMA / PMN Number
    123622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    SC200 3.0 AND CARTOSOUND NOT VALIDATED. SUBSEQUENT VALIDATION FINDINGS IDENTIFIED ERROR WITH DEPTH NOT UPDATING ON SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227960 ACUSON DIAGNOSTIC ULTRASOUND DEVICE IYN SIEMENS MEDICAL SOLUTIONS USA INC. ACUSON SC2000

    Patients

    Seq Age Sex Outcome Treatment
    1