AFFINITI CVX ULTRASOUND SYSTEM
Report
- Report Number
- 3019216-2023-00004
- Event Type
- Malfunction
- Date Received
- January 12, 2023
- Date of Event
- November 3, 2022
- Report Date
- September 5, 2024
- Manufacturer
- PHILIPS ULTRASOUND
- Product Code
- IYN
- PMA / PMN Number
- K212777
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PREVIOUSLY REPORTED, THE ROTARY ARM LOCKING DEVICE OF THE ULTRASONIC SYSTEM CONTROL PANEL HAD MALFUNCTIONED, RESULTING IN INCORRECT LOCKING ON THEIR AFFINITI CVX ULTRASOUND SYSTEM. THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS EVENT. THE CUSTOMER CONFIRMED THE ISSUE WAS MISREPORTED AND THERE WAS NO ACTUAL OCCURRENCE.
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.
EVALUATION OF THE SUSPECT CONTROL PANEL WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS RETURN AND INVESTIGATION COMPLETION.
PREVIOUSLY REPORTED, THE ROTARY ARM LOCKING DEVICE OF THE ULTRASONIC SYSTEM CONTROL PANEL HAD MALFUNCTIONED, RESULTING IN INCORRECT LOCKING ON THEIR AFFINITI CVX ULTRASOUND SYSTEM. THERE WAS NO ADVERSE PATIENT OR USER IMPACT ASSOCIATED WITH THIS EVENT. THE CUSTOMER CONFIRMED THE ISSUE WAS MISREPORTED AND THERE WAS NO ACTUAL OCCURRENCE.
THE CUSTOMER REPORTED THAT THE AFFINITI ULTRASOUND SYSTEM CONTROL PANEL WAS SWIVELING AND NOT LOCKING DURING TRANSPORT WITHIN THE SITE. THERE WAS NO INJURY OR CLINICAL USE ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1464198 | AFFINITI CVX ULTRASOUND SYSTEM | SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | IYN | PHILIPS ULTRASOUND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |