BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON SEQUOIA ULTRASOUND SYSTEM

    MDR report key: 19840528 · Received July 26, 2024

    Report

    Report Number
    3023245-2024-00043
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    July 20, 2022
    Report Date
    January 29, 2025
    Manufacturer
    SIEMENS HEALTHINEERS
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS CREATED AS A RESULT OF THE RETROSPECTIVE REVIEW PER EQMS-CAPA-001508 IMPLEMENTATION ACTION. REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT (MFR# 3023245-2024-00043) WAS BEING SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW PERFORMED BY SIEMENS ULTRASOUND. THIS REPORT IS BEING SUBMITTED AS THE INVESTIGATION IS COMPLETED. IN THIS CASE, SERVICE REVIEWED THE LOG FILES AND INITIALLY STATED THE PROBLEM COULD BE A NETWORK ISSUE. THE SOFTWARE WAS THEN RELOADED AND THE ISSUE WAS RESOLVED AT THE SITE. THE ISSUE DID NOT RECUR. HOWEVER, SINCE THE SOFTWARE WAS RELOADED ON THE SYSTEM TO RE-INITIALIZE THE DATABASE. IF ANY UN-ARCHIVED STUDIES WERE IN THE DATABASE, THEY WOULD BE LOST. REFERENCE# (B)(4).

    Description of Event or Problem · 0

    RETROSPECTIVE REVIEW - DATABASE ERROR WITH THE ACUSON SEQUOIA SYSTEM. SYSTEM DEVELOPED A DATABASE ERROR DURING SCANNING AND WILL NOT FUNCTION. IMAGING WORKS BUT CANNOT STORE IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459631 ACUSON SEQUOIA ULTRASOUND SYSTEM ULTRASOUND DEVICE IYN SIEMENS HEALTHINEERS 11148775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization