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

Catalog Number	11148775
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	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The damaged equipment has been replaced with a same model unit.The customer's daily operations have returned to normal.Country rfa, provided via pqif complaint form: (b)(4).
Event or Problem Description
On the daily work preparations process, the customer suddenly discovered thick smoke and flames emanating from the rear of the equipment.After an immediate cutting off the power supply and inspection, the customer found obvious burn marks on the cables at the dp interface of the input/output ports.Following the customer's report of the incident, company cse conducted an on-site inspection and confirmed that the dp video output cable had significant burn marks at the interface, rendering the equipment unable to power on.Aside from the equipment itself, there was no other personal injury or property damage.Company has urgently coordinated with sales partner to procure a demo unit of the same model for the customer's use.The company has had preliminary discussions with the customer regarding the aftermath.The damaged equipment will be returned to the company for further technical evaluation.The customer's daily work has not been affected in any other way.

• 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: 24376636
• Report Number: 3023245-2026-00020
• Device Sequence Number: 20069088
• Product Code: IYN
• UDI-Device Identifier: 04056869173566
• UDI-Public: 4056869173566
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: 11148775
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 02/18/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown