BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON SC2000 ULTRASOUND SYSTEM

    MDR report key: 19844796 · Received July 26, 2024

    Report

    Report Number
    3023245-2024-00051
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    March 14, 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 MDR (MFR# 3023245-2024-00051) WAS SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW PERFORMED BY SIEMENS. THIS REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION RELATED TO THE INVESTIGATION RESULTS. REVIEW OF THE SERVICE TICKET FOUND THAT SERVICE REVIEWED THE LOG FILES AND FOUND THE SYSTEM HANG WITH A RAD ERROR ON 3/14. ALSO, THERE WERE SOME SOFTWARE ERRORS IN THE LOGS. CSE RELOADED SOFTWARE AND REPLACED THE POWER SUPPLY MODULE. THE REPLACEMENT FIXED THE HANG ISSUE, BUT THE UNIT WOULD NOT BOOT. AFTER TROUBLESHOOTING, THE MBM250, HDD WERE REPLACED, AND THE SW WAS RE-INSTALLED TO GET THE SYSTEM WORKING. 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 - ACUSON SC2000 UNIT HUNG DURING STRESS ECHO EXAM. SYSTEM HUNG ON SHUTDOWN AFTER PERFORMING DIAGNOSTICS. NO INFORMATION ON HOW EXAM COMPLETED AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587536 ACUSON SC2000 ULTRASOUND SYSTEM ULTRASOUND DEVICE IYN SIEMENS HEALTHINEERS 10433816

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization