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

Model Number	ACUSON SEQUOIA
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is a duplicate report replacing 33009498591-2024-00001 an investigation is ongoing at siemens healthineers to identify the root cause of the issue.The report will be supplemented after the investigation is completed.Reference# (b)(4).
Event or Problem Description
System crashed during exam.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide investigation information.After evaluation it was not possible to determine the root cause based on the information provided.Reference# (b)(4).

• Brand Name: ACUSON SEQUOIA
• Common Device Name: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 22010 south east 51st street; issaquah, WA 98029
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA, INC.; 22010 south east 51st street; issaquah, WA 98029
• Manufacturer Contact: pragya kumar ; 22010 south east 51st street; issaquah, WA 98029
• MDR Report Key: 19754589
• Report Number: 3023245-2024-00035
• Device Sequence Number: 15666119
• Product Code: IYN
• UDI-Device Identifier: 04056869173566
• UDI-Public: 04056869173566
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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
• Operator of Device: Health Professional
• Device Model Number: ACUSON SEQUOIA
• Device Catalogue Number: 11148775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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