FDA Adverse Event
Malfunction
Summary report: N
2250051-2008-00453
MDR report key: 1252443
·
Received September 25, 2008
Report
- Report Number
- 2250051-2008-00453
- Event Type
- Malfunction
- Date Received
- September 25, 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 BAD TIP CLAMP. REPLACED TIP CLAMP LLD SPRING AND PLUNGER CLAMP. THE INSTRUMENT WAS CLEANED, INSPECTED, TESTED WITHOUT FURTHER PROBLEM AND RETURNED TO EXPECTED OPERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JTC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |