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

Model Number	10436113
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Z6ms (sn: (b)(6)) probe error usacquisitionhw_31 occurs every time when the probe is connected.This occurred during a valve replacement.The customer took out the transducer from the patient's esophagus and replaced with a different tee transducer and system (of a different company).The surgery was completed successfully with no patient consequence.
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).
Additional Manufacturer Narrative
This supplemental report is being submitted to provide investigation information.The transducer was returned for analysis.No information on the device history record which indicates any non-conformance at the moments of manufacturing process.System error was reproduced during testing.This issue was due to electrical component (fpcb) trace micro crack because of gastro flex malfunction.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: 21615302
• Report Number: 3023245-2025-00037
• Device Sequence Number: 7554259
• Product Code: ITX
• UDI-Device Identifier: 04056869002804
• UDI-Public: (01)04056869002804
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2025

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: 10436113
• 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: 03/16/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown