FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1970044
·
Received January 14, 2011
Report
- Report Number
- 1644487-2011-00044
- Event Type
- Malfunction
- Date Received
- January 14, 2011
- Date of Event
- December 1, 2010
- Report Date
- December 15, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PHYSICIAN'S DELL X50 SCREEN WAS FROZEN ON THE HARD RESET SCREEN WHERE THERE IS A MESSAGE THAT ASKS THE USER TO "CLEAR ALL DATA". THE MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TROUBLESHOOT WHERE THE LOCK BUTTON WAS NOT IN THE LOCK POSITION, AND HARD RESET WAS PERFORMED, AND THE SCREEN CONTINUED TO FREEZE AT THE MESSAGE THAT ASKS THE USER TO "CLEAR ALL DATA". THE PHYSICIAN WAS SENT A NEW HANDHELD TO REPLACE THE NON-WORKING DEVICE, AND THE NON-WORKING HANDHELD WAS RETURNED TO MANUFACTURER WHERE ANALYSIS IS UNDERWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |