FDA Adverse Event
Malfunction
Summary report: N
AFFINITI CVX ULTRASOUND SYSTEM
MDR report key: 25095011
·
Received May 6, 2026
Report
- Report Number
- 3019216-2026-100189
- Event Type
- Malfunction
- Date Received
- May 6, 2026
- Date of Event
- April 22, 2026
- Report Date
- May 6, 2026
- Manufacturer
- PHILIPS ULTRASOUND, INC
- Product Code
- IYN
- UDI-DI
- 00884838126909
- PMA / PMN Number
- K212777
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THE AFFINITI CVX ULTRASOUND SYSTEM, ALONG WITH AN X8-2T TRANSDUCER, WAS NOT AVAILABLE DURING AN OPEN-HEART SURGERY. THE SYSTEM LOCKED UP DURING USE. THE SYSTEM AND TRANSDUCER WERE EXCHANGED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT OR USER HARM. THE FIELD SERVICE ENGINEER EVALUATED THE SYSTEM BASED ON THE REPORTED PROBLEM AND CONFIRMED ERROR MESSAGES IN THE SYSTEM LOGS. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 270393 | AFFINITI CVX ULTRASOUND SYSTEM | SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | IYN | PHILIPS ULTRASOUND, INC | AFFINITI CVX | 00884838126909 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |