FDA Adverse Event
Malfunction
Summary report: N
2250051-2008-00064
MDR report key: 1003945
·
Received February 1, 2008
Report
- Report Number
- 2250051-2008-00064
- Event Type
- Malfunction
- Date Received
- February 1, 2008
- Product Code
- JTC
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUMENT HAS BEEN INVESTIGATED. THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND FOUND ONE TIP EJECT SLEEVE STUCK, AND ANOTHER TIP EJECT SLEEVE AND CLIP BROKEN IN THE REPORTED PROBLEM AREA OF THE PIPETTE ASSEMBLY. A TIP CLAMP AND TIP RETAINING CLIP WERE REPLACED. THE INSTRUMENT WAS CLEANED, INSPECTED , TESTED WITHOUT FURTHER PROBLEM, AND RETURNED TO SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JTC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |