BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON REDWOOD ULTRASOUND SYSTEM

    MDR report key: 19283041 · Received May 9, 2024

    Report

    Report Number
    3023245-2024-00025
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    March 21, 2024
    Report Date
    May 9, 2024
    Manufacturer
    SIEMENS HEALTHINEERS
    Product Code
    IYN
    PMA / PMN Number
    K210743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN IN-HOUSE INVESTIGATION WAS PERFORMED ON (B)(6) 2024 TO EXAMINE THIS CUSTOMER REPORTED OBSERVATION. USING A REDWOOD SYSTEM AND AN EQUIVALENT TEST PHANTOM, 2D MEASUREMENTS WERE PERFORMED ON IMAGES TAKEN BY 3D/4D PROBES. THE RESULTS OF THE 2D MEASUREMENTS FROM 3D/4D PROBE IMAGERY CONFIRM THE REPORTED HORIZONTAL ACCURACY IS OUTSIDE THE SPECIFIED TOLERANCE. THE INVESTIGATION IS ONGOING FOR THIS ISSUE. THIS REPORT WILL BE SUPPLEMENTED AFTER FURTHER INFORMATION IS RECEIVED. REFERENCE# (B)(4).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO DOCUMENT THE ROOT CAUSE INVESTIGATION OF THE EVENT. THE TECHNICAL ROOT CAUSE IS CONSIDERED TO BE THE GEOMETRY DESIGN PARAMETER VALUES OPTIMIZED DURING INITIAL DEVELOPMENT AND VERIFICATION. A TRANSDUCER'S GEOMETRIC PARAMETER VALUES ARE OPTIMIZED THROUGH CALIBRATION DURING AN IMAGE OPTIMIZATION PROCESS. THE 9VE4 AND 7VC2 GEOMETRY ASSESSMENTS WERE DONE DURING DEVELOPMENT (REFER TO "K2 R1.05 9VE4 DESIGN REVIEW"). DEVELOPMENT TESTING WAS DONE WITH A HORIZONTAL DISTANCE OF 30 MM BETWEEN CALIPERS AT A DEPTH OF 20 MM. ALTHOUGH THE TESTING WAS PERFORMED ACCORDING TO CONDITIONS WITH THE IPT (IMAGE PERFORMANCE TEST) PROCEDURE 10786930-EIT-001-04, THE TEST DID NOT SCREEN FOR ACCURACY WITHIN ADDITIONAL HORIZONTAL DISTANCES, SUCH AS 10 MM DEPTHS FROM THE CUSTOMER PROVIDED COMMENTARY. AN ABSENCE OF DIVERSE MEASUREMENTS ACROSS VARIOUS HORIZONTAL DISTANCES AND DEPTHS IS CONSIDERED TO BE THE REASON WHY THE OPTIMIZED GEOMETRIC PARAMETER VALUES IN THE PPC (PROBE, PRESET AND CONFIGURATION) RESULT IN MEASUREMENT ACCURACY OUTSIDE OF THE GENERAL SPECIFIED TOLERANCE. THIS REPORT WILL BE SUPPLEMENTED IF ADDITIONAL INFORMATION IS RECEIVED. REFERENCE# (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A SIGNIFICANT UNDERESTIMATION OF HORIZONTAL CALIPER MEASUREMENTS WHEN TESTING ON IMAGES TAKEN FROM TRANSDUCER MODELS 7VC2 AND 9VE4 WITH ON THE SIEMENS ACUSON REDWOOD SYSTEM. THE CUSTOMER REPORTED THE RESULTS WERE OUTSIDE THE STATED ACCURACY TOLERANCE OF 3% OF THE DISTANCE OR 1.5 MM. THE TEST WAS PERFORMED USING A TEST RMI404 GSE PHANTOM REPORTEDLY WITHIN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTS OF INJURY DUE TO THE ISSUE. THIS CUSTOMER RAISED THE SAME ISSUE ON TWO (2) SEPARATE SYSTEMS AT THEIR SITE, WHICH OCCURRED ON (B)(6) 2024. THUS, TWO (2) REPORTS ARE BEING SUBMITTED (3023245-2024-00024 AND 3023245-2024-00025).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771536 ACUSON REDWOOD ULTRASOUND SYSTEM ULTRASOUND DEVICE IYN SIEMENS HEALTHINEERS 11503314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention