MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC CX50; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number CX50 DIAGNOSTIC ULTRASOUND SYSTEM

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/21/2023

Event Type  malfunction  

Event Description

The cx50 ultrasound system was not available during a critical procedure.It was reported the surgeon required echo imaging to show the position of the venous and arterial cannula that was being inserted from the femoral vessels in a time critical fashion due to the patient's right ventricle breach at the sternotomy causing life-threatening hemorrhage and necessitating emergency cardiopulmonary bypass.It was reported the system took a long time to start up, then within 2 minutes of use the system reported the transesophageal probe had reached a temperature of 41.9 c, and then reported a fatal error and became unresponsive.An alternative cx50 machine had to be used for the procedure.There was no patient or user harm associated with this event.Additional information is being gathered regarding event details and the root cause of the issue, which will be included in a follow up report.

• Brand Name: CX50
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: thuy nguyen ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 18426123
• MDR Text Key: 332603122
• Report Number: 3019216-2024-00002
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K081802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CX50 DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795076
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1