MAUDE Adverse Event Report: SIEMENS 4C1 TRANSDUCER (MP); ULTRASOUND DEVICE

Model Number 4C1

Device Problem Overheating of Device (1437)

Patient Problem Skin Burning Sensation (4540)

Event Date 10/31/2023

Event Type  malfunction  

Manufacturer Narrative

This mdr will be supplemented if additional information is received.Reference complaint # (b)(4).

Event Description

It was reported that a patient underwent an ultrasound exam which included a 4c1 transducer (mp) in conjunction with the acuson s2000 and the patient's skin was allegedly burned by the transducer.It was reported that the transducer was evaluated for any damage and/or performance issues and replaced.Additional information was requested several times however, no additional information was received.

Manufacturer Narrative

This report is being submitted to document the root cause investigation of the event.Siemens investigated the issue and found no trouble or malfunction with the returned transducer.The reported issue could not be reproduced.This report will be supplemented if additional information is received.Reference#: (b)(4).

• Brand Name: 4C1 TRANSDUCER (MP)
• Type of Device: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS; 22010 se 51st st; issaquah WA 98029
• Manufacturer (Section G): SIEMENS; 22010 se 51st st; issaquah WA 98029
• Manufacturer Contact: jim dabbs ; 22010 se 51st st; issaquah, WA 98029
• MDR Report Key: 18235398
• MDR Text Key: 329314510
• Report Number: 3023245-2023-00026
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4C1
• Device Catalogue Number: 8258525
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1