MAUDE Adverse Event Report: SIEMENS HEALTHINEERS ACUNAV SWIFTLINK CABLE; ULTRASOUND TRANSDUCER

Model Number	8255715
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
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: cannot be determined.We were unable to identify the reported issue from the information provided.The root cause could not be determined at this time.Reference: (b)(4).
Event or Problem Description
This report is being submitted following a retrospective review performed by siemens ultrasound.In this case: blank screen during an ice exam and the acunav probe was not being.Recognized.All ports were tried and the acunav probe was being.Recognized.This occured today tuesday (b)(6) 2023, around 0800 local.Time.The customer used another system to complete the exam.

• Brand Name: ACUNAV SWIFTLINK CABLE
• Common Device Name: ULTRASOUND TRANSDUCER
• 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: 21290856
• Report Number: 3023245-2025-00019
• Device Sequence Number: 15787796
• Product Code: ITX
• UDI-Device Identifier: 04056869002804
• UDI-Public: (01)04056869002804
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: 8255715
• 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