FDA Adverse Event
Death
Summary report: N
LTV
MDR report key: 2444707
·
Received February 3, 2012
Report
- Report Number
- 2031702-2012-00043
- Event Type
- Death
- Date Received
- February 3, 2012
- Date of Event
- December 12, 2011
- Report Date
- February 2, 2012
- Manufacturer
- CAREFUSION 203, INC.
- Product Code
- CBK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT PASSED AWAY. THE FAMILY REPORTED THE VENTILATOR SHOULD HAVE ALARMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LTV | VENTILATOR, CONTINUOUS/CBK | CBK | CAREFUSION 203, INC. | LTV 950 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Death |