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

Model Number	AFFINITI CVX ULTRASOUND SYSTEM
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Codes	Cardiomyopathy (1764); Septic Shock (2068); Cardiogenic Shock (2262); Thromboembolism (2654); Heart Failure/Congestive Heart Failure (4446)
Date of Event	11/26/2025
Type of Reportable Event	Death
Event or Problem Description
A philips ultrasound system and model x7-2t transducer was associated with a patient death event.The patient underwent a cardiac procedure (implantation of an implantable cardioverter-defibrillator (icd)) for treatment of ventricular tachycardia.Additional follow-up care was needed 16 days later, and a device-related problem (deterioration in image quality) was reported during this incident.According to the customer, the image quality did not appear to have had any consequence on the subsequent course of care.The patient's condition deteriorated to multi-organ failure and the patient ultimately died a few days later of cardiogenic shock in the context of end-stage heart failure.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
The transducer was returned to philips for r&d assessment and evaluation.An investigation was conducted to determine the cause of the reported problem.While the image artifact described by the customer could not be replicated during testing, the noise pattern in the provided sample image aligns with behavior caused by an intermittent electrical connection, commonly associated with fluid intrusion or corrosion at the connector pins.Evidence of fluid exposure was found in both the transducer's mid-handle and also the system connector areas.Based on these findings, the most probable cause is an intermittent electrical connection due to fluid exposure.The transducer was replaced to address the customer's concerns, and no further similar events have been reported.

• Brand Name: AFFINITI CVX ULTRASOUND SYSTEM
• 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: 24526939
• Report Number: 3019216-2026-100081
• Device Sequence Number: 15892603
• Product Code: IYN
• UDI-Device Identifier: 00884838114166
• UDI-Public: (01)00884838114166
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K132304
• Number of Events Summarized: 1
• Summary Report (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): 06/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AFFINITI CVX ULTRASOUND SYSTEM
• Device Catalogue Number: 795190
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male