FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1081930
·
Received July 23, 2008
Report
- Report Number
- 1644487-2008-01678
- Event Type
- Malfunction
- Date Received
- July 23, 2008
- Date of Event
- June 1, 2008
- Report Date
- June 26, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
INITIAL REPORT INDICATED THAT THEIR DELL HANDHELD CONTAINING 7.1 SOFTWARE "SCREEN WAS FREEZING. IT FROZE AFTER INTERROGATION SUCCESSFUL BEEP, BUT DID NOT DISPLAY THE PATIENT DATA. PULLING THE CARD ALLOWED THE DEVICE TO CONTINUE." THE PRODUCT IS AT THE MANUFACTURER, PENDING COMPLETION OF ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 521373 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |