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

Model Number	11335791
Medical Device Problem Code	Loss of Data (2903)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
There was a symptom that the test was automatically terminated during the patient test this morning.(end exam).2) the patient data saved before was not saved, and we had no choice but to call the patient back and proceed with the examination again.3) this symptom occurred a week ago as well, and 2 cases occurred after ui update with vb10d.4) the images taken before the start of the test remain after the patient is called to the worklist, and the data taken after the start of the test are not saved.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide investigation information.The investigation was conducted based on the provided information.However, the engineer confirmed that no abnormalities related to the reported issue were found.Additionally, a review of the pairing between patient registration and end exam events revealed no anomalies.In this case, the exact root cause cannot be determined.According to the service activity result, the issue was resolved by reinstalling the software.No further investigation is possible at this moment.2025-00092757-1.

• Brand Name: ACUSON JUNIPER
• 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 kumar ; 22010 se 51st st; issaquah, WA 98029
• MDR Report Key: 21315715
• Report Number: 3023245-2025-00033
• Device Sequence Number: 12804095
• Product Code: IYN
• UDI-Device Identifier: 04056869152059
• UDI-Public: (01)04056869152059
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: 11335791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 07/01/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown