FDA Adverse Event
Malfunction
Summary report: N
3003135857-2007-00032
MDR report key: 979223
·
Received October 17, 2007
Report
- Report Number
- 3003135857-2007-00032
- Event Type
- Malfunction
- Date Received
- October 17, 2007
- Product Code
- CBK
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS: THE UNIT WAS TESTED AT TECHNICAL SERVICE. THE REPORTED SYMPTOM WAS DUPLICATED. THE BATTERY FAILURE WAS MOST LIKELY CAUSED BY TRICKLE CHARGE PROBLEM IN THE BATTERY CHARGING CIRCUIT, WHICH HAS BEEN IDENTIFIED BY FML. A DESIGN CHANGE HAS BEEN RELEASED BY FML. CONCLUSION: THE REPORTED FAILURE WAS CONFIRMED, WHICH WAS CAUSED BY A KNOWN TRICKLE CHARGE PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CBK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |