MAUDE Adverse Event Report: GE VINGMED ULTRASOUND AS; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	9VT-D
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
After the conclusion of the asd [atrial septal defect] closure procedure, transesophageal echocardiography, the patient developed a contact tear/burn due to the echo probe.

• Brand Name: NA
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): GE VINGMED ULTRASOUND AS; 3000 n. grandview blvd; waukesha WI 53188
• MDR Report Key: 22737187
• Report Number: 22737187
• Device Sequence Number: 9240212
• Product Code: ITX
• UDI-Device Identifier: 00195278388483
• UDI-Public: (01)00195278388483
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2025
• Report Date (Section F): 07/09/2025

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: 9VT-D
• Device Catalogue Number: KN100130
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2025
• 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 Age: 9 YR
• Patient Sex: Unknown
• Patient Weight: 29 KG
• Date Report Sent to FDA: 07/09/2025