MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC EPIQ CVX; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	EPIQ CVX
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported when releasing the front control panel handle lock on the epiq cvx ultrasound system, the control panel started to lower immediately and faster than expected.The failure occurred outside of clinical use, and no patient or user was harmed as a result of the issue.Nothing detached from the system.The philips service engineer replaced the control panel arm gas struts to resolve the customer¿s issue.Philips has started an investigation, and upon completion, a follow-up report will be submitted.
Additional Manufacturer Narrative
An investigation was performed to determine the cause of the reported problem.A qualified philips service engineer replaced the control panel arm gas struts to resolve the customer¿s immediate concerns.The investigation concluded the control panel lowered faster than normal when the lock was released due to degraded gas strut performance, this can occur as struts lose internal pressure over time and use.The issue was fully resolved in the field through replacement of both the actuation and non-actuation gas springs.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 NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: ondrea bermudez ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 24083023
• Report Number: 3019216-2026-100015
• Device Sequence Number: 20303128
• Product Code: IYN
• UDI-Device Identifier: 00884838107526
• UDI-Public: (01)00884838107526
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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 CVX
• 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: 12/26/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown