MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	11148775
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The touchscreen of the acuson sequoia ultrasound system froze during an exam, and health care provider was unable to use the machine until a manual restart was completed.This incident caused a delay in patient care.
Event or Problem Description
The touchscreen of the acuson sequoia ultrasound system froze during an exam, and health care provider was unable to use the machine until a manual restart was completed.This incident caused a delay in patient care.

• Brand Name: ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 22010 south east 51st street; mailcode: 64-1a; issaquah WA 98029 7002
• MDR Report Key: 13782108
• Report Number: 13782108
• Device Sequence Number: 19228668
• Product Code: IYN
• UDI-Device Identifier: 04056869173566
• UDI-Public: (01)04056869173566
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2022
• Report Date (Section F): 03/01/2022

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 03/16/2022
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2022
• Supplement Report FDA Received Date: 02/16/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/01/2022