FDA Adverse Event
Malfunction
Summary report: N
2250051-2008-00090
MDR report key: 1003045
·
Received February 11, 2008
Report
- Report Number
- 2250051-2008-00090
- Event Type
- Malfunction
- Date Received
- February 11, 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 REPLACED A TIP CLAMP IN THE REPORTED PROBLEM AREA OF THE PIPETTE ASSEMBLY. THE INSTRUMENT WAS 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 |