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

Model Number	11148775
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	02/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is being submitted following a retrospective review performed by siemens ultrasound.In this case: there was a sharp surface on the cp handle.When the sonographers grasp the control panel handle with their thumbs under, something scratches their thumbs or their hands.
Additional Manufacturer Narrative
This report is being submitted following a retrospective review performed by siemens ultrasound.Investigation was completed and it was found that: evaluation of a sample sequoia system showed that the damage was due to a 2mm gap between the plastic cover (part #11151465) and control panel bucket.By tightening the screws, the plastic cover is over-stressed and deformed until it cracks.This problem was addressed with a design change to the plastic cover.Two small rings were added to the top of the plastic (2mm high) to fill the gap.The change was implemented in eco 718576 (valid from 10/7/2020).The damage can be fixed on site for the customer with replacement of the plastic cover (part #11151465).Reference: (b)(4).

• 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: 21292419
• Report Number: 3023245-2025-00021
• Device Sequence Number: 7585907
• Product Code: IYN
• UDI-Device Identifier: 04056869173566
• UDI-Public: (01)04056869173566
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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