MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC. EPIQ 7C ULTRASOUND SYSTEM; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number 795201

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 08/11/2022

Event Type  malfunction  

Event Description

During cardiac surgery, transesophageal echocardiogram (tee) machine worked for initial exam.Subsequently the echo image froze and anesthesiologist was unable to complete echo.Steps taken to restart machine unsuccessful.New tee machine obtained from heart station.

• Brand Name: EPIQ 7C ULTRASOUND SYSTEM
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC.; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 16643244
• MDR Text Key: 312340409
• Report Number: 16643244
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/22/2023,09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 795201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Sex: Female