MAUDE Adverse Event Report: SIEMENS HEALTHINEERS ACUSON SC2000; ULTRASOUND DEVICE

Model Number	10433816
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This report is being submitted following a retrospective review performed by siemens ultrasound.In this case: customer complaining of system lockup during procedure at approximately 1300 on (b)(6) 2023.No serious or minor injuries were reported.The procedure was delayed and system had to be switched out for another unit to continue procedure.Logs were escalated to rsc/hsc.C: drive indicated full.
Additional Manufacturer Narrative
This report is being submitted following a retrospective review performed by siemens ultrasound.Investigation was completed and it was found that: logs showed disk corruption due to bad power downs.Software reload corrected issue.Reference: (b)(4).

• Brand Name: ACUSON SC2000
• 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: 21292268
• Report Number: 3023245-2025-00018
• Device Sequence Number: 9208024
• Product Code: IYN
• UDI-Device Identifier: 04056869002804
• UDI-Public: (01)04056869002804
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 10433816
• 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