FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1172123
·
Received September 18, 2008
Report
- Report Number
- 1644487-2008-02256
- Event Type
- Malfunction
- Date Received
- September 18, 2008
- Date of Event
- August 19, 2008
- Report Date
- August 19, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
CONCLUSIONS: DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE NURSE PRACTITIONER WAS OBTAINING AN ERROR MESSAGE, WHEN SHE WAS USING THE HANDHELD DEVICE. SHE RETURNED THE HANDHELD TO THE MANUFACTURER FOR ANALYSIS AND IT WAS DETERMINED THAT THE ERROR ORIGINATED IN THE SERIAL CABLE. DURING VISUAL INSPECTION OF THE SERIAL CABLE, A BROKEN RED WIRE CONNECTIONS IN THE (B) (4) CONNECTOR PLUG WAS IDENTIFIED. ONCE THE WIRE WAS RESOLDERED ONTO THE (B) (4) CONNECTOR PLUG, THE SERIAL CABLE WAS ABLE TO ESTABLISH COMMUNICATION BETWEEN THE HANDHELD DEVICE AND THE WAND. IT IS UNKNOWN WHAT CAUSED THE WIRE TO BREAK BUT IT IS MOST LIKELY RELATED TO MISHANDLING OF THE SERIAL CABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |