FDA Adverse Event
Death
Summary report: N
LTV
MDR report key: 2070266
·
Received April 19, 2011
Report
- Report Number
- 2031702-2011-00079
- Event Type
- Death
- Date Received
- April 19, 2011
- Date of Event
- March 8, 2011
- Report Date
- April 19, 2011
- Manufacturer
- CAREFUSION 203, INC.
- Product Code
- CBK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- RESPIRATORY THERAPIST
Narratives
Additional Manufacturer Narrative · 1
THIS MDR IS BEING FILED BEYOND THE 30 DAY REPORTING TIMELINE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PARENTS FOUND THE PT UNRESPONSIVE WITH SECRETIONS COMING FROM THE PT'S NOSE. THE VENTILATOR WAS STILL VENTILATING WITH NO ALARMS. THE PARENTS PERFORMED CPR, 911 WAS CALLED, AND THE PT WAS TAKEN TO THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LTV | VENTILATOR, CONTINUOUS / CBK | CBK | CAREFUSION 203, INC. | LTV 1150 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 MO | Death |