FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1052075
·
Received May 20, 2008
Report
- Report Number
- 1644487-2008-01183
- Event Type
- Malfunction
- Date Received
- May 20, 2008
- Date of Event
- April 21, 2008
- Report Date
- April 22, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
INITIAL REPORTER INDICATED THAT THEIR DELL HANDHELD HAD "HANDHELD COMPUTER SCREEN STALLS AFTER INTERROGATION, THE HANDHELD IS MANUALLY TURNED OFF AND THEN BACK ON IN ORDER TO PROCEED TO FOLLOWING SCREEN. THE HANDHELD WAS FUNCTIONING VERY SLOWLY." THE HANDHELD CONTAINED 7.1 PROGRAMMING SOFTWARE. THE PRODUCT IS AT MFR PENDING COMPLETION OF PRODUCT ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 537100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |