MAUDE Adverse Event Report: SIEMENS HEALTHINEERS ACUSON S1000; ULTRASOUND DEVICE

Model Number	10441701
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
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: root cause is unknown.No root cause for the issue could be determined as the customer did not provide the information necessary to complete an investigation and has refused service.Siemens was not contacted for service, therefore no logs, pictures or any other details were provided.Reference: (b)(4).
Event or Problem Description
This report is being submitted following a retrospective review performed by siemens ultrasound.In this case: 1.The customer found that the system could get hang up frequently, causing all buttons to lose response.Customer attempted to restart the device without any improvement.The customer immediately arranged for the patient to complete the examination in another room.No other patients were affected.After the incident, the customer did not report to siemens.They reported the incident to regulatory authority as ae, siemens was required to evaluate the potential risk.2.Hospital's ae report described incident as "on (b)(6) 2024, doctors performed amniocentesis on patients under the guidance of the ultrasound diagnostic system.During the puncture process, the ultrasound diagnostic system suddenly went black and failed to continue superconductivity.Even after restarting, it still could not be turned on normally, and the black screen remained in a continuous state.Immediately start another bedside ultrasound machine to continue performing amniocentesis for the patient.If the patient does not experience any special discomfort after the surgery, report to the department director.".

• Brand Name: ACUSON S1000
• 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: 21292497
• Report Number: 3023245-2025-00010
• Device Sequence Number: 9208025
• Product Code: IYN
• UDI-Device Identifier: 04056869002750
• UDI-Public: (01)04056869002750
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Operator of Device: Health Professional
• Device Model Number: 10441701
• 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 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