FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1070420
·
Received July 3, 2008
Report
- Report Number
- 1644487-2008-01512
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- June 4, 2008
- Report Date
- June 4, 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
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED THAT THEIR HP JORNADA HANDHELD SCREEN KEPT FREEZING. HARD AND SOFT RESETS WERE DONE BUT THEY STILL HAD THE SAME ISSUE. AFTER A HARD RESET WAS PERFORMED THE HANDHELD WOULD TURN OFF. THEN AFTER TAKING BOTH BATTERIES THE SCREEN WOULDN'T RESPOND SO YOU COULDN'T GET PAST THE "SCREEN ALIGN" SCREEN. PRODUCT ANALYSIS IS PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 521426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |