FDA Adverse Event
Injury
Summary report: N
LTV
MDR report key: 2434448
·
Received January 26, 2012
Report
- Report Number
- 2031702-2012-00035
- Event Type
- Injury
- Date Received
- January 26, 2012
- Date of Event
- November 25, 2011
- Report Date
- January 26, 2012
- Manufacturer
- CAREFUSION 203, INC
- Product Code
- CBK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VENTILATOR HAD A LOW PRESSURE ALARM AND LOW MINUTE VOLUME ALARM. THE PATIENT WAS IN RESPIRATORY DISTRESS AND HAD TO BE 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 950 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Hospitalization| L |