FDA Adverse Event
Malfunction
Summary report: N
AFFINITI CVX ULTRASOUND SYSTEM
MDR report key: 17379711
·
Received July 24, 2023
Report
- Report Number
- 3019216-2023-00106
- Event Type
- Malfunction
- Date Received
- July 24, 2023
- Date of Event
- June 28, 2023
- Manufacturer
- PHILIPS ULTRASOUND, INC
- Product Code
- IYN
- UDI-DI
- 00884838106598
- PMA / PMN Number
- K132304
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE AFFINITI CVX ULTRASOUND CONTROL PANEL'S SWIVEL LOCK ASSEMBLY BECAME UNSEATED PREVENTING THE MECHANISM FROM LOCKING IN PLACE. WHILE TRANSPORTING THE SYSTEM WITHIN THE FACILITY, THE CONTROL PANEL ASSEMBLY WOULD SWING FROM SIDE TO SIDE. THE DETENT RELEASE CABLE WAS ADJUSTED TO CORRECT THE FAILURE.
Description of Event or Problem · 0
A CUSTOMER REPORTED THAT THE CONTROL PANEL ARM WAS SWIVELING DURING TRANSPORT OF AN AFFINITI CVX ULTRASOUND SYSTEM. THE DEVICE WAS NOT IN CLINICAL USE AT TIME OF DISCOVERY. NO PATIENT OR USER WAS HARMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470902 | AFFINITI CVX ULTRASOUND SYSTEM | SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | IYN | PHILIPS ULTRASOUND, INC | AFFINITI CVX ULTRASOUND SYSTEM | 00884838106598 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |