MAUDE Adverse Event Report: SIEMENS HEALTHINEERS 5C1 TRANSDUCER (MP456); ULTRASOUND DEVICE

Model Number	5C1
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	07/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient stated she was shocked by 5c1 transducer, sn (b)(6).The probe was immediately removed from service and the exam was completed.Patient stated after the exam there was no resulting injury.
Additional Manufacturer Narrative
This mdr will be supplemented if additional information is received.Reference complaint #(b)(4).
Additional Manufacturer Narrative
This supplemental report is being submitted to provide investigation information.In this case, the 5c1 mp456 transducer was returned for an electrical shock issue.The transducer passed leakage and hi-pot safety test.The root cause could not be determined.Siemens continues to track and trend any incidents related to this issue.The transducer has been replaced at the site.(b)(4).

• Brand Name: 5C1 TRANSDUCER (MP456)
• Common Device Name: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS HEALTHINEERS; 22010 se 51st st; issaquah WA 98029
• Manufacturer (Section G): SIEMENS HEALTHINEERS; 22010 se 51st st; issaquah WA 98029
• Manufacturer Contact: pragya kumar ; 22010 se 51st st; issaquah, WA 98029
• MDR Report Key: 19754912
• Report Number: 3023245-2024-00036
• Device Sequence Number: 15700186
• Product Code: ITX
• UDI-Device Identifier: 04056869061870
• UDI-Public: 04056869061870
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 5C1
• Device Catalogue Number: 11291794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female