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

Model Number EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM

Device Problem Unintended System Motion (1430)

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

Event Date 01/14/2023

Event Type  malfunction  

Event Description

A customer reported the swivel mechanism of their epiq 7c ultrasound system¿s control panel did not lock properly while transporting the unit within the user facility.The failure occurred outside of clinical use and no patient or user was harmed as a result of the issue.

Manufacturer Narrative

A customer reported the swivel mechanism of their epiq 7c ultrasound system¿s control panel did not lock properly while transporting the unit within the user facility.The philips field service engineer performed an inspection and found the bushing had popped up not allowing the plunger to reach the lock position.The fse replaced the lock mechanism and bushing to repair the system.A thorough investigation was performed to identify the root cause of the reported issue.The engineering team determined the failure was caused by a hardware issue in the articulating arm latching mechanism preventing the locking solenoid from fully engaging.This action was reported to fda per 21 cfr part 806 on 7/16/21.Reference corrections and removal report number 3019216-07/16/21-002-c.

• Brand Name: EPIQ 7
• 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: eric nail ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 16240413
• MDR Text Key: 308117454
• Report Number: 3019216-2023-00008
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838097872
• UDI-Public: 00884838097872
• 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
• 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: 01/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/28/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 3019216-07/16/21-002-C
• Patient Sequence Number: 1