FDA Adverse Event
Malfunction
Summary report: N
C-VIEW
MDR report key: 1948632
·
Received December 30, 2010
Report
- Report Number
- 3007540658-2010-00002
- Event Type
- Malfunction
- Date Received
- December 30, 2010
- Date of Event
- August 20, 2010
- Report Date
- August 20, 2010
- Manufacturer
- CARROT MEDICAL LLC
- Product Code
- DXJ
- PMA / PMN Number
- K083321
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE MONITOR DISPLAY HAS NOISE INTERMITTENTLY IN THE TWO LEFT QUADRANTS OF THE SCREEN. THE NOISE APPEARS TO BE FLASHING WHITE HORIZONTAL LINES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | C-VIEW | DISPLAY, CATHODE-RAY, MEDICAL | DXJ | CARROT MEDICAL LLC | 1005436 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |