FDA Adverse Event
Malfunction
Summary report: N
3003135857-2006-00050
MDR report key: 795988
·
Received October 25, 2006
Report
- Report Number
- 3003135857-2006-00050
- Event Type
- Malfunction
- Date Received
- October 25, 2006
- Product Code
- CBK
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
H3: DEVICE EVALUATED BY MFR? THE VENTILATOR WAS REC'D BY NEWPORT MEDICAL INSTRUMENTS INC ON 10/13/06. 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. PLEASE NOTE THAT THERE WAS NO PT INVOLVEMENT IN THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CBK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |