FDA Adverse Event
Malfunction
Summary report: N
3003135857-2008-00006
MDR report key: 1020782
·
Received February 5, 2008
Report
- Report Number
- 3003135857-2008-00006
- Event Type
- Malfunction
- Date Received
- February 5, 2008
- Product Code
- CBK
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATED BY MFR? THE VENTILATOR WAS RETURNED TO NEWPORT MEDICAL INSTRUMENTS INC ON 1/30/08. 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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |