MAUDE Adverse Event Report: TEE PROBE; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Device Problems No Display/Image (1183); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 08/20/2021

Event Type  malfunction  

Event Description

Intraprocedural tee image ceased to be shown from the echo machine.The machine was exchanged, but probe was found to be the culprit.The faulty probe was removed and new probe inserted to complete the procedure.Fda safety report id # (b)(4).

• Brand Name: TEE PROBE
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• MDR Report Key: 12447045
• MDR Text Key: 271001251
• Report Number: MW5103807
• Device Sequence Number: 1
• Product Code: ITX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR