FDA Adverse Event
Injury
Summary report: N
LTV
MDR report key: 2002319
·
Received February 15, 2011
Report
- Report Number
- 2031702-2011-00276
- Event Type
- Injury
- Date Received
- February 15, 2011
- Date of Event
- January 10, 2011
- Report Date
- February 15, 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
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
PATIENT'S FAMILY REPORTED THAT THE VENTILATOR WAS NOT BLOWING AIR, WHILE CONNECTED TO THE PATIENT. IT IS UNKNOWN IF THE VENTILATOR ALARMED. THE PATIENT WAS TAKEN OFF THE VENTILATOR AND AMBU BAGGED UNTIL THE EMERGENCY MEDICAL SERVICES ARRIVED. THE PATIENT WAS TAKEN TO THE HOSPITAL WITH A DIAGNOSIS OF PNEUMONIA.
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 | 54 YR | Hospitalization |