MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON X300 PE; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	10566144
Medical Device Problem Code	Loss of Data (2903)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).
Event or Problem Description
When attempting to save an image, the save failed.The issue was not resolved, but the procedure was completed without problems.The procedure was completed without patient's consequence.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide investigation information and to update product information in section d.Attempts to retrieve the required information for investigation were made, however it was not provided from the site.In this case, the root cause cannot be determined.Based on a review of complaints over the past two years, we checked whether there were any similar cases related to the x300 product and confirmed that there have been no data loss cases occurring during high-risk examinations.And according to the complaint description, the procedure was successfully completed without any problems.There was no serious injury or clinical impact on the patient.Siemens will continue to track and monitor for trending purposes.Reference number: (b)(4).

• Brand Name: ACUSON X300 PE
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 22010 se 51st st; issaquah WA 98029
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA, INC.; 22010 se 51st st; issaquah WA 98029
• Manufacturer Contact: pragya jai kumar ; 22010 se 51st st; issaquah, WA 98029 ; 6506257209
• MDR Report Key: 24100638
• Report Number: 3023245-2026-00003
• Device Sequence Number: 10295885
• Product Code: IYN
• UDI-Device Identifier: 04056869001029
• UDI-Public: 04056869001029
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10566144
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 03/04/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown