MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC. TRANSDUCER X7-2T; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/09/2022

Event Type  malfunction  

Event Description

An intraoperative transesophageal echocardiogram (tee) was being conducted by the anesthesia provider after induction but prior to surgical incision.The image from the philips tee transducer was very poor, and the anesthesia provider was unable to confirm that the mitral valve repair was leaking.The tee probe was removed, marked for repair, and replaced with a different tee probe.According to the anesthesia provider, the image on the 2nd tee probe was only marginally better and he still wasn't able to visualize the mitral valve leak.The surgeon was called to the room to discuss cancelling the procedure.The surgeon and the anesthesia provider reviewed the pre-operative echo from the cardiology office and were able to identify the mitral valve leak.The procedure proceeded as planned.

• Brand Name: TRANSDUCER X7-2T
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC.; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 14694925
• MDR Text Key: 294037724
• Report Number: 14694925
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2022
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Sex: Female