FDA Adverse Event
Malfunction
Summary report: N
2250051-2009-00018
MDR report key: 1321004
·
Received January 30, 2009
Report
- Report Number
- 2250051-2009-00018
- Event Type
- Malfunction
- Date Received
- January 30, 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 FOUND INTERMITTENT DAMAGED TIPS AFTER REPORTED LLD ISSUE. FSE VERIFIED ADJUSTMENTS WERE STILL GOOD, TIPS ALIGNED PROPERLY AND GO INTO PROPER POSITIONS CLEANLY. FSE WAS ABLE TO RUN SPLLD AND DEMO PLATES WITHOUT ISSUE. INSTRUMENT IS OPERATING AS EXPECTED. THE INSTRUMENT WAS TESTED WITHOUT FURTHER PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JTC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |