FDA Adverse Event
Malfunction
Summary report: N
2250051-2008-00445
MDR report key: 1250443
·
Received September 18, 2008
Report
- Report Number
- 2250051-2008-00445
- Event Type
- Malfunction
- Date Received
- September 18, 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 BROKEN TIP CLAMP. CLEANED PLUNGER CLAMP, SPRING AND TIP SLEEVE. REPLACED THE TIP CLAMP. RAN THE SPLLD AND OAS USER SOFTWARE WITH ALL TIPS DISPENSING. 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 |