FDA Adverse Event
Malfunction
Summary report: N
9616240-2006-00341
MDR report key: 727670
·
Received June 14, 2006
Report
- Report Number
- 9616240-2006-00341
- Event Type
- Malfunction
- Date Received
- June 14, 2006
- Product Code
- FII
- PMA / PMN Number
- k001156
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
NO PT INJURY WAS REPORTED. A GAMBRO TECHNICAL SERVICES (GTS) FIELD REP INSPECTED THE MACHINE AND FOUND BROKEN SPRING IN BLOOD PUMP ROTOR. HE REPLACED THE BLOOD PUMP ROTOR. 510(K)# IS K001156
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FII |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |