FDA Adverse Event
Malfunction
Summary report: N
2250051-2009-00008
MDR report key: 1299889
·
Received January 27, 2009
Report
- Report Number
- 2250051-2009-00008
- Event Type
- Malfunction
- Date Received
- January 27, 2009
- 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 ALL TIP CLAMPS, PLUNGER CLAMPS AND LLD SPRINGS. CLEANED TIP EJECTION SLEEVES AND COMPRESSION SPRING. THE INSTRUMENT WAS TESTED WITHOUT FURTHER PROBLEM AND WAS RETURNED TO EXPECTED OPERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JTC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |