MAUDE Adverse Event Report: SIEMENS HEALTHINEERS ACUSON SEQUOIA; ULTRASOUND DEVICE

Model Number	11148775
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted following a retrospective review performed by siemens ultrasound.Investigation was completed and it was found that: after evaluation it was not possible to determine the root cause.Reference: (b)(4).
Event or Problem Description
This report is being submitted following a retrospective review performed by siemens ultrasound.In this case: the sonographer maintains that the cine clip button was repeatedly used during a high-risk ob exam.When the system was brought back to the department, they could not be viewed on the system or on the pacs system.It is unknown if the cine-clip thumbnails were noted on the side of the monitor during the study.

• Brand Name: ACUSON SEQUOIA
• Common Device Name: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS HEALTHINEERS; 22010 south east 51st street; issaquah WA 98029
• Manufacturer (Section G): SIEMENS HEALTHINEERS; 22010 south east 51st street; issaquah WA 98029
• Manufacturer Contact: pragya jai kumar ; 22010 south east 51st street; issaquah, WA 98029
• MDR Report Key: 21292199
• Report Number: 3023245-2025-00015
• Device Sequence Number: 9244882
• Product Code: IYN
• UDI-Device Identifier: 04056869173566
• UDI-Public: (01)04056869173566
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/01/2025

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 Model Number: 11148775
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown