FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1191914
·
Received October 1, 2008
Report
- Report Number
- 1644487-2008-02376
- Event Type
- Malfunction
- Date Received
- October 1, 2008
- Date of Event
- September 4, 2008
- Report Date
- September 4, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ERROR MESSAGE "CF CARD WARNING" WAS RECEIVED WHENEVER THE NURSE TURNED THE HANDHELD. SHE PERFORMED ROUTINE TROUBLESHOOTING SUCH AS PERFORMING A SOFT RESET, REMOVED THE FLASHCARD, AND PERFORMED A HARD RESET; HOWEVER, THE ERROR MESSAGE WOULD NOT CLEAR. A REPLACEMENT HANDHELD DEVICE WAS SENT TO THE NURSE. GOOD FAITH ATTEMPTS TO GET THE HANDHELD RETURNED TO THE MFR FOR ANALYSIS HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | MUZ | CYBERONICS, INC. | 250 | 521384 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |