MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC EPIQ 7 C ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Catalog Number PB016180

Device Problem No Device Output (1435)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2023

Event Type  malfunction  

Event Description

It was reported the epiq 7 c ultrasound system displayed an error code and would not connect the verisight pro catheter or display images.The procedure was not specified but it was reported the catheter was inside the patient¿s body and advancing to a lesion.The catheter was exchanged to complete the procedure.There was no reported patient or user harm.Philips has started an investigation of this complaint.

Manufacturer Narrative

A thorough investigation was performed which found the error code was due to a transducer power fault, which means a power supply to the catheter had exceeded the acoustic power limits.The issue was related to the catheter and not the ultrasound system.The issue was resolved by using a different catheter.

• Brand Name: EPIQ 7 C 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: 17651961
• MDR Text Key: 322304767
• Report Number: 3019216-2023-00129
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PB016180
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2024
• 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