FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1071713
·
Received July 9, 2008
Report
- Report Number
- 1644487-2008-01568
- Event Type
- Malfunction
- Date Received
- July 9, 2008
- Date of Event
- June 9, 2008
- Report Date
- June 9, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT AN HP JORNADA'S HANDHELD SCREEN WAS FREEZING. THE SCREEN WOULD FREEZE WHEN THE HANDHELD WAS POWERED ON. TROUBLESHOOTING WOULD NOT RESOLVE THE ISSUE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. PRODUCT ANALYSIS REVEALED THAT THE PRODUCT PERFORMED ACCORDING TO SPECIFICATIONS, AND NO ANOMALIES WERE IDENTIFIED THAT COULD SUPPORT THE REPORTED COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 521426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |