BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON S3000 ULTRASOUND SYSTEM

    MDR report key: 4550839 · Received February 19, 2015

    Report

    Report Number
    3009498591-2015-00005
    Event Type
    Malfunction
    Date Received
    February 19, 2015
    Date of Event
    January 9, 2015
    Report Date
    August 9, 2018
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA INC.
    Product Code
    IYN
    PMA / PMN Number
    123622
    Removal / Correction Number
    Z-2321-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO SIEMENS FOR INVESTIGATION; HOWEVER, A HEALTH RISK EVALUATION (HRE) WAS CONDUCTED TO FIND THE ROOT CAUSE OF THE REPORTED PHENOMENON. BASED ON THE HRE, THE BASIC ROOT CAUSE IS ATTRIBUTED TO COLOR MAPPING WHICH MISALIGNED WITH THE B-MODE IMAGE UNDERNEATH. WHAT THIS RESULTS IN FOR THE USER IS A DIFFERENCE BETWEEN THE COLOR BAR MAPPING AND THE SHEAR WAVE VELOCITY READOUT. THE VELOCITY RESULT IN M/S DOES NOT CORRESPOND WITH THE VELOCITY COLOR SCALE. THE ROOT CAUSE IS DUE TO A GEOMETRY DISTORTION ERROR OF THE INPUT PARAMETER TO THE SCAN CONVERTER, RESULTING IN AN INCORRECT SHEAR WAVE VELOCITY RESULT. REFERENCE COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    WHEN USING VTIQ IN A BREAST EXAM, THE SHEAR WAVE VELOCITY READING IN M/S DID NOT MATCH THE COLOR SCALE. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120633 ACUSON S3000 ULTRASOUND SYSTEM DIAGNOSTIC ULTRASOUND DEVICE IYN SIEMENS MEDICAL SOLUTIONS USA INC. ACUSON S3000

    Patients

    Seq Age Sex Outcome Treatment
    1