BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON SEQUOIA ULTRASOUND SYSTEM

    MDR report key: 19841474 · Received July 26, 2024

    Report

    Report Number
    3023245-2024-00044
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    August 3, 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

    THE INITIAL MDR (MFR# 3023245-2024-00044) 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, IT WAS REPORTED THAT THE SYSTEM LEFT SPEAKER HAD LOUD NOISE, THE SYSTEM ALSO FROZE DURING EXAM AND AN UNKNOWN EXAM HAD TO BE RESCANNED. NO PATIENT HARM HAS BEEN REPORTED. THE CSE ARRIVED ON SITE AGAIN AND RESEATED ALL CP-IOM CABLING. LOGS WERE COLLECTED FOR FURTHER ANALYSIS. REVIEW OF LOGS BY SERVICE FOUND EVIDENCE OF POTENTIAL CEM / GPU FAULT AS BOTH VIDEO AND AUDIO ARE SOURCED FROM GPU. THE SAM WAS REPLACED AND NO FURTHER PROBLEMS REPORTED. THE AUDIO EXTRACTION AND AMPLIFICATION ARE IN THE SAM UNIT. THIS IS A ONE-OFF HARDWARE FAILURE CASE AND NO TRENDS HAVE BEEN IDENTIFIED. REFERENCE# (B)(4).

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    RETROSPECTIVE REVIEW - WHILE USING THE ACUSON SEQUOIA SYSTEM THERE WAS A LOUD SCREECHING NOISE FROM LEFT SPEAKER DURING EXAM. CUSTOMER TRIED TURNING THE SYSTEM OFF BUT IT FROZE, SO HAD TO RESET AT THE WALL. THE NOISE WAS GOING, BUT IT DIDN'T SAVE IMAGES SO HAD TO RESCAN THE PATIENT. UNKNOWN EXAM TYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587332 ACUSON SEQUOIA ULTRASOUND SYSTEM ULTRASOUND DEVICE IYN SIEMENS HEALTHINEERS 11148775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization