FDA Adverse Event
Other
Summary report: N
9611500-2008-00026
MDR report key: 1130943
·
Received August 7, 2008
Report
- Report Number
- 9611500-2008-00026
- Event Type
- Other
- Date Received
- August 7, 2008
- Product Code
- CBK
- PMA / PMN Number
- K974176
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
A BROKEN FLOW SENSOR RESULTS IN ALARMS OF THE BABYLOG 8000 VENTILATOR. THE FLOW SENSOR PARTS WERE REQUESTED FOR INVESTIGATION, BUT NOT YET RECEIVED. INVESTIGATION RESULTS WILL BE REPORTED IN A FOLLOW UP REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CBK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |