MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC EPIQ CVX ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Catalog Number 795237

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 03/01/2024

Event Type  Injury  

Event Description

A serious injury was reported after using an s7-3t transducer and an epiq cvx ultrasound system.A patient was having a transesophageal echocardiography with no sign of a product malfunction.The patient had a fever afterwards and tests were performed the following week to confirm a perforation of the esophagus.The patient will receive unspecified ongoing treatment.No information was provided about the details of the perforation or the medical interventions the patient received.The cause of the perforation has not been determined.Philips has started an investigation of this complaint.

• Brand Name: EPIQ CVX ULTRASOUND SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• 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: 18887500
• MDR Text Key: 337459840
• Report Number: 3019216-2024-00034
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838088658
• UDI-Public: 00884838088658
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 795237
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention