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

Model Number	EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported the swivel mechanism of their epiq cvx 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.A replacement bearing was sent to the customer to resolve the immediate issue.A thorough engineering investigation has been performed to identify the root cause of the reported issue.The engineering team determined the failure was a hardware issue in the articulating arm latching mechanism preventing the locking solenoid from fully engaging.
Additional Manufacturer Narrative
H10 philips has started an investigation, and upon completion, a follow-up report will be submitted.H11 the following information was omitted on the initial report.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.
Additional Manufacturer Narrative
H10: it was initially reported that the resolution for the customer was that a replacement bearing was sent to the customer, however reseating and applying loctite glue to bushing resolved the immediate issue.The bearing was only shipped directly to customer for use in future repairs.H11: a thorough investigation was performed to determine the cause of the reported problem.It was determined that the application of adhesive was inadequate, allowing for the bearing to become unsecured and preventing the locking solenoid from fully engaging.The system has returned to service with no similar issues reported post repair.

• Brand Name: EPIQ CVX
• Common Device Name: 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: roxanne ramirez ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 22336621
• Report Number: 3019216-2025-000234
• Device Sequence Number: 15707514
• Product Code: IYN
• UDI-Device Identifier: 00884838097933
• UDI-Public: (01)00884838097933
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K132304
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795231
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 05/29/2025; 07/02/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 06/26/2025; 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3019216-07/16/21-002-C
• Patient Sequence Number: 1
• Patient Sex: Unknown