MAUDE Adverse Event Report: SIEMENS HEALTHINEERS ACUSON X300 PE; ULTRASOUND DEVICE

Model Number	10566144
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
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: based on the information provided, the reported issue was solved by reinstalling the sw.As we could not get the information such as logs, further investigation could not be performed.A root cause cannot be determined.Reference: (b)(4).
Event or Problem Description
This report is being submitted following a retrospective review performed by siemens ultrasound.In this case: it becomes a 2d screen, but button operations do not work at all.

• Brand Name: ACUSON X300 PE
• 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: 21292562
• Report Number: 3023245-2025-00017
• Device Sequence Number: 12699367
• Product Code: IYN
• UDI-Device Identifier: 04056869002835
• UDI-Public: (01)04056869002835
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: 10566144
• Was Device Available for Evaluation?: No
• 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): 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