FDA Adverse Event
Malfunction
Summary report: N
LTV
MDR report key: 1933964
·
Received December 1, 2010
Report
- Report Number
- 2031702-2010-00233
- Event Type
- Malfunction
- Date Received
- December 1, 2010
- Report Date
- November 29, 2010
- Manufacturer
- CAREFUSION 203, INC
- Product Code
- CBK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- SERVICE AND TESTING PERSONNEL
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
THE VENTILATOR WAS AT THE FIELD SERVICE CENTER FOR A SCHEDULED PREVENTATIVE MAINTENANCE. DURING SERVICE, IT WAS REPORTED THAT THE VENTILATOR TURBINE WAS NOT OPERATING.
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 | NA |