MAUDE Adverse Event Report: SIEMENS HEALTHINEERS ACUSON Z6MS ULTRASOUND TRANSDUCER; ULTRASOUND DEVICE

Model Number	11575187
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
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
During a cardiac exam, the z6ms transducer image could not be adjusted.The angle could not be fixed when looking at the image and it returned 0.There was no patient injury and another system was used to complete the exam.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide investigation information.The transducer was not replaced and therefore an investigation could not be performed.A probable root cause was determined as manufacturing issue with the coaxial cables.Cable assembly design change with new strain relief has been released via eco#705619 and 706446 (cable assembly s/n cut: (b)(6).Xdcr s/n cut: (b)(6)).This has been implemented at susko factory in oct.2020.Reference# (b)(4).

• Brand Name: ACUSON Z6MS ULTRASOUND TRANSDUCER
• 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: 23273902
• Report Number: 3023245-2025-00064
• Device Sequence Number: 9775061
• Product Code: ITX
• UDI-Device Identifier: 04056869002804
• UDI-Public: (01)04056869002804
• 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,Followup
• Report Date (Section B): 10/11/2025

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: 11575187
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2025
• Supplement Report FDA Received Date: 11/19/2025
• 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