FDA Adverse Event
Summary report: N
VELA
MDR report key: 3042194
·
Received April 2, 2013
Report
- Report Number
- 3042194
- Date Received
- April 2, 2013
- Date of Event
- August 12, 2012
- Report Date
- August 16, 2012
- Manufacturer
- CAREFUSION 211, INC.
- Product Code
- CBK
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
ISSUES WITH INSPIRATORY VOLUMES MATCHING EXPIRATORY VOLUMES.======================MANUFACTURER RESPONSE FOR TRANSPORT VENTILATOR, VELA (PER SITE REPORTER).======================CAREFUSION REPRESENTATIVE CAME IN TO INVESTIGATE ISSUE. HE DID EXTENSIVE TESTING AND FOUND NO PROBLEMS WITH VENTILATOR.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134397 | VELA | VENTILATOR | CBK | CAREFUSION 211, INC. | VELA D | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |