FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1885034
·
Received October 20, 2010
Report
- Report Number
- 1644487-2010-02349
- Event Type
- Malfunction
- Date Received
- October 20, 2010
- Date of Event
- January 1, 2010
- Report Date
- September 21, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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
IT WAS REPORTED THAT A NEUROLOGIST HAD ISSUES WITH HER HANDHELD COMPUTER AS INITIALLY IT WOULD NOT POWER ON. A HARD RESET WAS PERFORMED ON THE HANDHELD AFTER VERIFYING THE HANDHELD WAS NOT ON LOCKED. THE HANDHELD COMPUTER WENT THROUGH THE ALIGN SCREEN AFTER THE HARD RESET AND THE SCREEN WENT BLANK. MOREOVER, THE NEUROLOGIST STATED THE HANDHELD HAD BEEN CHARGED. A NEW HANDHELD COMPUTER WAS SENT TO THE NEUROLOGIST AND THE REPORTED HANDHELD COMPUTER WAS RETURNED TO THE MANUFACTURER TO UNDERGO PRODUCT ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 715910 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |