FDA Adverse Event
Malfunction
Summary report: N
2250051-2009-00069
MDR report key: 1327091
·
Received February 19, 2009
Report
- Report Number
- 2250051-2009-00069
- Event Type
- Malfunction
- Date Received
- February 19, 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 DRIED SERUM ON TIP AND PLUNGER CLAMP ON POSITION #2. ALSO FOUND WORN 2-POLE RIBBON CABLE ON POSITION #2. FSE REPLACED THE TIP CLAMP, PLUNGER CLAMP, AND 2-POLE RIBBON CABLE ON POSITION #2. DURING FUNCTIONAL TESTING, FSE RECEIVED INTERMITTENT LLD ERRORS ON PRIMARY RACK FOR POSITION #2. FSE REPLACED DEFECTIVE TUBE LIFTER. 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 |