FDA Adverse Event
Malfunction
Summary report: N
3003135857-2006-00068
MDR report key: 830276
·
Received January 11, 2007
Report
- Report Number
- 3003135857-2006-00068
- Event Type
- Malfunction
- Date Received
- January 11, 2007
- Product Code
- CBK
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATED BY MFR. THE VENTILATOR WAS RECEIVED BY NEWPORT MEDICAL INSTRUMENTS INC ON 12/18/2006. IT WILL BE FORWARDED TO MANUFACTURER/FLIGHT MEDICAL LTD FOR FURTHER INVESTIGATION. A FAILURE ANALYSIS REPORT AND ACTION TAKEN IN RESOLVING THIS ISSUE WILL BE SUBMITTED TO MEDWATCH PROGRAM. PLEASE NOTE THAT THERE WAS NO DEATH OR NO SEVERE INJURY INVOLVED IN THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CBK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |