FDA Adverse Event
Malfunction
Summary report: N
2250051-2008-00107
MDR report key: 1013029
·
Received February 26, 2008
Report
- Report Number
- 2250051-2008-00107
- Event Type
- Malfunction
- Date Received
- February 26, 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 A COLLET CONTAMINATED WITH SERUM IN THE REPORTED PROBLEM AREA OF THE PIPETTE ASSEMBLY. REPLACED COLLET AND CLEANED TIP-EJECT SLEEVE. REASSEMBLED ARM AND TESTED SUMMIT. 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 |