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

Model Number 795201

Device Problems Unintended System Motion (1430); Detachment of Device or Device Component (2907)

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

Event Date 01/30/2023

Event Type  malfunction  

Manufacturer Narrative

Return of the suspect defective part is anticipated.Evaluation of the defective part will be included in a follow up report upon its return and investigation completion.

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.No patient or user was harmed as a result of the issue.

Manufacturer Narrative

Initially it was reported an investigation would be performed on the defective part; however, this is a known cause.A philips service engineer replaced the articulation arm 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 7C DIAGNOSTIC ULTRASOUND SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRAS
• Manufacturer (Section D): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: thuy nguyen ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 16312391
• MDR Text Key: 308973725
• Report Number: 3019216-2023-00012
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 795201
• Device Catalogue Number: 795201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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