BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON REDWOOD

    MDR report key: 20637584 · Received November 8, 2024

    Report

    Report Number
    3023245-2024-00062
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    November 5, 2024
    Report Date
    November 7, 2024
    Manufacturer
    SIEMENS HEALTHINEERS
    Product Code
    IYN
    UDI-DI
    04056869251264560070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS CONDUCTED WITH PROVIDED INFORMATION AND THE REPORTED ISSUE WAS CAUSED BY A SOFTWARE CODING ERROR OF THE MEASUREMENT RATIO TOOL. ASSESSMENT OF THE SOFTWARE CODE DETERMINED THE RATIO WAS CODED ACCORDING TO MEASUREMENT ORDER, RATHER THAN CODED TO THE SPECIFIED DISTANCE VALUE. PER THE CODE, THE FIRST PERFORMED DISTANCE MEASUREMENT IS ALWAYS DIVIDED BY THE SECOND DISTANCE MEASUREMENT. THEREFORE, WHEN A B-MODE IMAGE DISTANCE IS MEASURED FIRST, AS IN THE CUSTOMER COMPLAINTS, THE INVERSE RATIO VALUE IS CALCULATED AND DISPLAYED. BASED ON THE RESULT OF HRE, THE RISK INDEX 6.5 RESIDUAL RISK IS 2A BUT THE RESULT OF THIS RISK WAS ASSESSED AS 1A. NO CAPA WAS REQUIRED. SEVERITY OF HARM ASSOCIATED WITH THIS IS A LEVEL [1], NEGLIGIBLE INJURY PROBABILITY OF OCCURRENCE OF HARM IS IMPROBABLE [A] RISK INDEX [I] - GENERALLY ACCEPTABLE, BELOW RISK ACCEPTABILITY THRESHOLD THE HRE ASSESSES THE RISK AS ACCEPTABLE FOR NOT PROVIDING A FIELD PROVISION OF A CORRECTIVE SOLUTION SYSTEM, AND THAT CURRENTLY DISTRIBUTED REDWOOD SYSTEMS WILL CONTINUE TO BE ABLE TO MANIFEST THIS DEFECT. THIS ISSUE WAS ADDRESSED IN REDWOOD VA30A. REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS ONGOING AT SIEMENS HEALTHINEERS TO IDENTIFY THE ROOT CAUSE OF THE ISSUE. THE REPORT WILL BE SUPPLEMENTED AFTER THE INVESTIGATION IS COMPLETED. REFERENCE# (B)(4).

    Description of Event or Problem · 0

    STRAIN IMAGING EI/B RATIO IS NOT CALCULATED ACCORDING TO MEASUREMENT LABELS. WORKFLOW FOR REPRODUCE: 18L6 BREAST EXAM, VT STRAINING IMAGING. 1. MEASUREMENT MODE, ACTIVATE "EI/B RATIO - D." 2. MEASURE DISTANCE ON B MODE IMAGE D (B) MEASUREMENT VALUE IS DISPLAYED ON IMAGE SCREEN. 3. MEASURE DISTANCE ON ELASTO IMAGE D (E) MEASUREMENT VALUE IS DISPLAYED ON IMAGE SCREEN. 4. THE EI /B DISTANCE RATIO IS CALCULATED, BUT RESULT IS B/EI DISTANCE RATIO, NOT EI/B DISTANCE RATIO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1877029 ACUSON REDWOOD ULTRASOUND DEVICE IYN SIEMENS HEALTHINEERS 11503314 04056869251264560070

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown