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

Catalog Number	10433816
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	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
01/dec/2025 - eaf - initial clarification - wwc.
Event or Problem Description
The image quality is not sharp, delay in response when pushing the buttons specifically with stress, dgc not reacting to slider position.

• 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: 24801242
• Report Number: 3023245-2026-00031
• Device Sequence Number: 21318300
• Product Code: IYN
• UDI-Device Identifier: 04056869002804
• UDI-Public: 4056869002804
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 10433816
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 04/07/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown