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

Catalog Number	11148775
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This complaint ticket is being migrated from gsms (pm00379059, date complaint created: 06/10/2024) to smartsolve as a part of the gsms sunset project (gsms shuts down on 01-oct-2024).The investigation will be completed and documented in the smartsolve complaint ticket.Missing images.
Additional Manufacturer Narrative
Exam was redone.Collect logs and image included with complaint form.Forward to hsc.

• 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: christine dunn ; 22010 se 51st st; issaquah, WA 98029 ; 4257851617
• MDR Report Key: 21750839
• Report Number: 3009498591-2025-00010
• Device Sequence Number: 8220637
• Product Code: IYN
• UDI-Device Identifier: 04056869173566
• UDI-Public: 4056869173566
• 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): 03/31/2025

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: 06/10/2024
• Initial Report FDA Received Date: 04/02/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown