MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC.; ULTRASOUND

Catalog Number	11668590
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Save logs were captured, patient de-identified and put onto usb.Patient is being called back for a secondary stress echo since it is inconclusive.
Event or Problem Description
On (b)(6) 8 am central time a full echo was performed and a report was saved, without ending the exam the sonographer then went into stress echo protocol (treadmill contrast) and performed normal rest and post images.Measurements were made on the post stress images for ejection fraction.The sonographer stored a secondary report that included the stress post measurements.The study was ended and scent to picom (pacs).On (b)(6) am, one of the physicians called saying there are no stress echo images seen only the original full echo.When i arrived, it was past 24 hours and you can no longer append images.The full original exam was seen, and the post images with contrast that were measured for ejection fraction as well as the post stress report.However, there were no stress echo images on the study.The images jumped from number 91 to number 183 on the thumbnails, with nothing in between.

• Common Device Name: ULTRASOUND
• 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: 24801244
• Report Number: 3023245-2026-00030
• Device Sequence Number: 13247934
• Product Code: IYN
• UDI-Device Identifier: 04056869996295
• UDI-Public: 04056869996295
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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
• Device Catalogue Number: 11668590
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 04/07/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown