FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 3121786
·
Received May 21, 2013
Report
- Report Number
- 1644487-2013-01487
- Event Type
- Malfunction
- Date Received
- May 21, 2013
- Date of Event
- January 1, 2013
- Report Date
- April 25, 2013
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ANALYSIS OF THE COMPUTER AND FLASHCARD WAS COMPLETED. NO ANOMALIES ASSOCIATED WITH THE HANDHELD COMPUTER WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. DURING THE FLASHCARD ANALYSIS, NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.
Description of Event or Problem · 1
REPORTER INDICATED A VNS DELL X5 COMPUTER WAS FREEZING DURING INTERROGATION AND AT THE ¿INTERROGATION SUCCESSFUL¿ SCREENS. THE SCREEN FREEZING RESOLVED WITH PERFORMING A HARD RESET, BUT THE EVENT RECURS. THE COMPUTER AND FLASHCARD HAVE BEEN RETURNED AND ANALYSIS IS PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 223525 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 1073773 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |