FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1052241
·
Received May 23, 2008
Report
- Report Number
- 1644487-2008-01214
- Event Type
- Malfunction
- Date Received
- May 23, 2008
- Date of Event
- April 1, 2008
- Report Date
- April 25, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO MFR THAT THE HAND HELD SCREEN WAS BROKEN AND THAT ONLY THREE VERTICAL LINES WERE DISPLAYED WHEN POWERED ON. TROUBLESHOOTING WAS PERFORMED AND THE SCREEN PROBLEM DID NOT RESOLVE. THE SITE HAS DENIED ANY TRAUMA TO THE DEVICE. THE HAND HELD DEVICE WAS RETURNED TO MFR FOR ANALYSIS. THE HANDHELD DEVICE WAS POWERED USING THE RETURNED AC POWER SUPPLY. DURING POWER UP IT WAS IDENTIFIED THAT THE SCREEN IMAGE WAS DISTORTED. THE SCREEN IMAGE HAD 3 DARK VERTICAL LINES. THIS IS AN INDICATION THAT THE SCREEN IS DEFECTIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | NONE | LYJ | CYBERONICS, INC. | 250 | 521409 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |