FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 1201325
·
Received July 23, 2008
Report
- Report Number
- 2250051-2008-00362
- Event Type
- Malfunction
- Date Received
- July 23, 2008
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Product Code
- JTC
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUMENT HAS BEEN INVESTIGATED. THE FIELD SVC ENGINEER (FSE) EVALUATED THE INSTRUMENT AND FOUND COLLET STUCK IN ROW 5. NEW PLUNGER CLAMP, TIP CLAMP, AND LID SPRING INSTALLED IN ROW 5. CLEANED COLLET IN ROW 5. THE INSTRUMENT WAS TESTED WITHOUT FURTHER PROBLEM AND RETURNED TO EXPECTED OPERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | JTC | ORTHO-CLINICAL DIAGNOSTICS, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |