BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON SEQUOIA ULTRASOUND SYSTEM

    MDR report key: 19843312 · Received July 26, 2024

    Report

    Report Number
    3023245-2024-00045
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    September 12, 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 (B)(4). IMPLEMENTATION ACTION. REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR (MFR# 3023245-2024-00045) WAS SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW PERFORMED BY SIEMENS. THIS REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION RELATED TO THE INVESTIGATION RESULTS. SERVICE REVIEWED THE LOG FILES AND FOUND POST IDPROM CHECKSUM TEST FAILED FOR TPM HW: TPM SW: US_PST US_SXP CONTEXT: INDICATES TPM FRU IDENTIFICATION INFORMATION INTEGRITY CHECK FAILED. THEREFORE, THE TPM WAS REPLACED AND THE SW WAS RELOADED BY SERVICE. THE ISSUE DID NOT RECUR. NO TRENDS WERE FOUND FOR THIS ISSUE; THUS NO FURTHER ACTION IS REQUIRED. REFERENCE# (B)(4).

    Description of Event or Problem · 0

    RETROSPECTIVE REVIEW - SEQUOIAST IDPROM ERROR ON ACUSON SEQUOIA SYSTEM. THE SYSTEM SHOWED AN ERROR MESSAGE DURING OPERATION. NOW IT BOOTS TO ERROR SCREEN. REBOOTING DID NOT SOLVE THE ISSUE. UNKNOWN EXAM TYPE OR HOW THE EXAM WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458796 ACUSON SEQUOIA ULTRASOUND SYSTEM ULTRASOUND DEVICE IYN SIEMENS HEALTHINEERS 11148775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization