FDA Adverse Event
Malfunction
Summary report: N
AFFINITI CVX ULTRASOUND SYSTEM
MDR report key: 16073829
·
Received December 29, 2022
Report
- Report Number
- 3019216-2022-00120
- Event Type
- Malfunction
- Date Received
- December 29, 2022
- Date of Event
- December 1, 2022
- Report Date
- September 5, 2024
- Manufacturer
- PHILIPS ULTRASOUND
- Product Code
- IYN
- UDI-DI
- 00884838106598
- PMA / PMN Number
- K132304
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
EVALUATION OF THE AFFINITI CVX ULTRASOUND SYSTEM WILL BE INCLUDED IN A FOLLOW-UP REPORT UPON INVESTIGATION COMPLETION.
Additional Manufacturer Narrative · 0
THE FIELD SERVICE ENGINEER (FSE) REPLACED THE TOUCH PANEL TO CORRECT THE FAILURE. A THOROUGH INVESTIGATION WAS PERFORMED TO IDENTIFY THE ROOT CAUSE OF THE REPORTED ISSUE. THE ENGINEERING TEAM CONFIRMED THAT THE TOUCH PANEL ISSUE WAS NOT REPRODUCIBLE.
Additional Manufacturer Narrative · 0
AN ADDENDUM REPORT IS BEING SUBMITTED TO PROVIDE THE DATE RECEIVED BY MANUFACTURER WITH THE PHILIPS¿ BECOME AWARE DATE. THE INFORMATION IS IN THE G3 FIELD.
Description of Event or Problem · 0
A CUSTOMER REPORTED THAT AN AFFINITI CVX ULTRASOUND SYSTEM WAS SHUTTING DOWN ON ITS OWN. IT IS UNKNOWN IF THIS OCCURRED DURING A CRITICAL PROCEDURE. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2424947 | AFFINITI CVX ULTRASOUND SYSTEM | SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | IYN | PHILIPS ULTRASOUND | AFFINITI CVX DIAGNOSTIC ULTRASOUND SYSTEM | 00884838106598 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |