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

Catalog Number	10436113
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that when connecting the z6ms probe, the device displays the error us acquisition hw_31 and the system requests the removal of the probe.The issue is thermal in nature and occurs every time the probe is connected.When connecting v5m tee probes, the error does not occur.
Additional Manufacturer Narrative
No service activity yet.

• 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: 24376637
• Report Number: 3023245-2026-00017
• Device Sequence Number: 4942061
• Product Code: ITX
• UDI-Device Identifier: 04056869003634
• UDI-Public: 04056869003634
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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: 10436113
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 02/18/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown