FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 1012139
·
Received February 20, 2008
Report
- Report Number
- 3003135857-2008-00011
- Event Type
- Malfunction
- Date Received
- February 20, 2008
- Manufacturer
- FLIGHT MEDICAL LTD.
- Product Code
- CBK
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATED BY MFR? THE VENTILATOR WAS RETURNED ON 2/4/2008. IT WILL BE FORWARDED TO MFR/FLIGHT MEDICAL LTD FOR FURTHER INVESTIGATION. A FAILURE ANALYSIS REPORT AND ACTION TAKEN IN RESOLVING THIS ISSUE WILL BE SUBMITTED TO MEDWATCH PROGRAM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | CBK | FLIGHT MEDICAL LTD. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |