BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON SC2000 ULTRASOUND SYSTEM

    MDR report key: 19973464 · Received August 13, 2024

    Report

    Report Number
    3023245-2024-00056
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    August 8, 2024
    Report Date
    September 27, 2024
    Manufacturer
    SIEMENS HEALTHINEERS
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS ONGOING AT SIEMENS HEALTHINEERS TO IDENTIFY THE ROOT CAUSE OF THE ISSUE. THE REPORT WILL BE SUPPLEMENTED AFTER THE INVESTIGATION IS COMPLETED. REFERENCE# (B)(4).

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE INVESTIGATION INFORMATION. IN THIS CASE, THE ROOT CAUSE OF THIS ISSUE WAS DETERMINED TO RESULT FROM A SOFTWARE EXCEPTION ERROR DURING THE STRESS ECHO EXAM. THE PROBABLE REASON FOR THE ERROR IS DUE TO THE STRESS ECHO SUBSYSTEM ATTEMPTING TO ACCESS A BACKUP FILE BEING CONTROLLED BY SOLIDCORE AT THE SAME TIME. SOFTWARE WAS RELOADED ON THE SYSTEM TO RESOLVE THE ISSUE. THE OCCURRENCE OF THIS ERROR WAS RESOLVED VIA A FIX IN SOFTWARE. REFERENCE#: (B)(4).

    Description of Event or Problem · 0

    WHILE USING THE SC2000 FOR A DOBUTAMINE STRESS TEST, AN ERROR MESSAGE APPEARED. THIS OCCURRED DURING POST IMAGING. AFTER THE ERROR MESSAGE POPPED UP, THE CUSTOMER WAS UNABLE TO REVIEW ALL THE IMAGES FROM THE STRESS TEST STAGES INCLUDING BASELINE, FIRST STAGE, AND POST INFUSION. THEY DECIDED TO END THE STUDY, HOPING THE IMAGES WOULD BE PRESERVED AND TRANSFERRED TO THE PACS SYSTEM. HOWEVER, THIS DID NOT HAPPEN AND DATA WAS LOST. THE FILE ONLY CONTAINED IMAGES CAPTURED PRIOR TO STARTING THE STRESS TEST. THE EXAMINATION HAD TO BE REPEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639271 ACUSON SC2000 ULTRASOUND SYSTEM ULTRASOUND DEVICE IYN SIEMENS HEALTHINEERS 10433816

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| H