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

Model Number	795190
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A qualified field service engineer assessed the reported behavior on-site and collected all available diagnostic and error logs for analysis.The engineering team performed a comprehensive review of the captured data, including log correlation, and attempts to reproduce the reported issue.The issue could not be reproduced, and no cause was able to be identified.At this time, no further similar issues have been reported for this device.
Event or Problem Description
It was reported the affiniti cvx ultrasound system was not available during a critical procedure.During a heart surgery, the system froze.The ultrasound system was exchanged to complete the procedure.There was no reported patient nor user harm associated with this event.Philips has started an investigation, and upon completion, a follow up report will be submitted.

• Brand Name: AFFINITI CVX DIAGNOSTIC ULTRASOUND SYSTEM
• 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: ondrea bermudez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 24526854
• Report Number: 3019216-2026-100080
• Device Sequence Number: 8430537
• Product Code: IYN
• UDI-Device Identifier: 00884838126909
• UDI-Public: (01)00884838126909
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K251651
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: 795190
• Device Catalogue Number: 795190
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2025
• 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