FDA Adverse Event
Malfunction
Summary report: N
2250051-2008-00091
MDR report key: 1003047
·
Received February 11, 2008
Report
- Report Number
- 2250051-2008-00091
- 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 FOUND A BAD LLD CONTACT SPRING IN THE REPORTED PROBLEM AREA OF THE PIPETTE ASSEMBLY. THE LDD CONTACT SPRING AND TIP CLAMP WERE REPLACED. 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 |