FDA Adverse Event
Malfunction
Summary report: N
PORTABLE VIDEO MONITOR, GVL-2000
MDR report key: 2972571
·
Received February 15, 2013
Report
- Report Number
- 9615393-2013-00090
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Date of Event
- January 18, 2013
- Report Date
- January 18, 2013
- Manufacturer
- VERATHON MEDICAL (CANADA) ULC
- Product Code
- CCW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
EVALUATION RESULTS PENDING ANALYSIS OF THE PRODUCT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER WAS HAVING DIFFICULTIES WITH SEEING THE VIDEO IMAGE ON THE MONITOR. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69842 | PORTABLE VIDEO MONITOR, GVL-2000 | NONE | CCW | VERATHON MEDICAL (CANADA) ULC | 0231-0003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |