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

Model Number	11668590
Medical Device Problem Code	Loss of Data (2903)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
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
Customer reported tee exam was lost, only single image of patient registration in patient folder.Customer stated that the unit did beep and thumbnails were generated along with measurements showing on screen, however when exam ended, nothing was available to review other than registration page image.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide investigation information.Software versions vb10, vb20 and vb30 have known performance issues when the patient database contains several hundred records.This is related to the known trends ¿firstcaptureslow¿ and ¿trend_imagesaveissue¿.Solution is to free up the patient database.Reference# (b)(4).

• Brand Name: ACUSON ORIGIN
• 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: 24576897
• Report Number: 3023245-2026-00027
• Device Sequence Number: 9435411
• Product Code: IYN
• UDI-Device Identifier: 04056869996295
• UDI-Public: 04056869996295
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 04/21/2026

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: 11668590
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/21/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown