BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON SEQUOIA

    MDR report key: 19845558 · Received July 26, 2024

    Report

    Report Number
    3023245-2024-00049
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    March 29, 2022
    Report Date
    January 29, 2025
    Manufacturer
    SIEMENS HEALTHINEERS
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE# (B)(4).

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR (MFR# 3023245-2024-00049) WAS SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW PERFORMED BY SIEMENS. THIS REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION RELATED TO THE INVESTIGATION RESULTS. IN THIS CASE, SERVICE ARRIVED AT THE SITE TO INVESTIGATE THE ISSUE WITH THE UNIT NOT SAVING SCREEN SHOT AND PRINTER ERROR, RELOADED THE SOFTWARE ON THE UNIT. HOWEVER, ONCE THE BACKUP PRESET FILES WERE LOADED, THE SYSTEM WOULDN'T LOAD IT. THE BACK-UP PRESET SEEMED TO BE CORRUPTED. THE PROBLEM WAS RESOLVED AFTER CSE RELOADED SOFTWARE AND ENTERED NETWORK DATA BY HAND. THE INABILITY TO SAVE IMAGES COULD BE DUE TO THE CORRUPTED PRESETS. NO TRENDS WERE FOUND FOR THIS ISSUE; THUS NO FURTHER ACTION IS REQUIRED. REFERENCE# (B)(4).

    Description of Event or Problem · 0

    PRINT/SAVE FAILURE WHEN ATTEMPTING TO SAVE IMAGES. PROBLEM STARTED AFTER CSE REPLACED CEM AND HARD DRIVE , LOADED SOFTWARE AND RESTORED BACKUPS. THIS MDR IS BEING SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922089 ACUSON SEQUOIA ULTRASOUND DEVICE IYN SIEMENS HEALTHINEERS 11148775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown