FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 1013586
·
Received February 29, 2008
Report
- Report Number
- 2250051-2008-00165
- Event Type
- Malfunction
- Date Received
- February 29, 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 COLLETS WITH EJECT SLEEVE JAMMED IN THE REPORTED PROBLEM OF THE PIPETTE ASSEMBLY. THE PREVENTIVE MAINTENANCE WAS PERFORMED. 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 | ORTHO-CLINICAL DIAGNOSTICS, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |