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

Catalog Number	10785577
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	08/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 13/aug/2025 - (b)(6) - call clarification on 14/august/2025 tse (b)(6), worked with the biomed to obtain notes for the depot repair to use for troubleshooting.
Event or Problem Description
Measurements are 3cm incorrect (shorter than expected), the measurements issue began wednesday (b)(6) 2025 while scanning an echo exam with the swiftlink cable & acunav probe.

• 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: 24376623
• Report Number: 3023245-2026-00008
• Device Sequence Number: 14687835
• Product Code: IYN
• UDI-Device Identifier: 04056869002743
• UDI-Public: 04056869002743
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/18/2026

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: 10785577
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 02/18/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown