MAUDE Adverse Event Report: SIEMENS HEALTHINEERS 6C1 HD TRANSDUCER, S2000; ULTRASOUND DEVICE

Model Number 6C1

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2024

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 while using the 6c1 transducer, patients feel tingling coming from the probe during ultrasounds.The probe membrane appears porous.The tingling sensation is prolonged throughout contact with the probe when there is gel between the probe and the skin.There was no serious shock or injuries reported and no medical intervention required.An order to replace the transducer has been placed by the customer.

• Brand Name: 6C1 HD TRANSDUCER, S2000
• Type of Device: 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 jai kumar ; 22010 se 51st st; issaquah, WA 98029
• MDR Report Key: 18966631
• MDR Text Key: 338767664
• Report Number: 3023245-2024-00012
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/24/2024

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 Operator: Health Professional
• Device Model Number: 6C1
• Device Catalogue Number: 10135941
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 03/24/2024
• Was Device Evaluated by Manufacturer?: No
• 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