FDA Adverse Event
Death
Summary report: N
LTV
MDR report key: 2444708
·
Received February 3, 2012
Report
- Report Number
- 2031702-2012-00040
- Event Type
- Death
- Date Received
- February 3, 2012
- Date of Event
- December 12, 2011
- Report Date
- February 1, 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
Additional Manufacturer Narrative · 1
NA.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT PASSED AWAY WHILE CONNECTED TO THE VENTILATOR. THE HOME CARE NURSE REPORTED THE VENTILATOR DID NOT ALARM. THE VENTILATOR WAS CHECKED OUT BY THE DEALER AND FOUND TO BE FUNCTIONING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LTV | VENTILATOR, CONTINUOUS/ CBK | CBK | CAREFUSION 203, INC. | LTV950 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Death |