FDA Adverse Event
Malfunction
Summary report: N
PORTABLE VIDEO MONITOR, GVL-2000
MDR report key: 2974069
·
Received February 19, 2013
Report
- Report Number
- 9615393-2013-00100
- Event Type
- Malfunction
- Date Received
- February 19, 2013
- Date of Event
- January 21, 2013
- Report Date
- January 21, 2013
- Manufacturer
- VERATHON MEDICAL (CANADA) ULC.
- Product Code
- CCW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION. THE REPORTED INCIDENT COULD NOT BE CONFIRMED.
Description of Event or Problem · 1
THE CUSTOMER CONTACTED VERATHON INC. REGARDING A PORTABLE VIDEO MONITOR GVL-2000 THAT IS DIM WITH ALL BLADES. THE CUSTOMER TRIED TO CHANGE THE DIMNESS AND BRIGHTNESS ON THE MONITOR AND THE RESULTS WERE STILL THE SAME. NO INJURY TO THE PATIENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 72446 | PORTABLE VIDEO MONITOR, GVL-2000 | NONE | CCW | VERATHON MEDICAL (CANADA) ULC. | 0231-0003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |