FDA Adverse Event
Malfunction
Summary report: N
LTV
MDR report key: 2133267
·
Received May 11, 2011
Report
- Report Number
- 2031702-2011-00097
- Event Type
- Malfunction
- Date Received
- May 11, 2011
- Date of Event
- April 1, 2011
- Report Date
- May 10, 2011
- Manufacturer
- CAREFUSION 203, INC
- Product Code
- CBK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- RESPIRATORY THERAPIST
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE VENTILATOR WAS SWITCHED FROM EXTERNAL BATTERY TO WALL POWER, THE VENTILATOR WOULD GO INOP WITH AN AUDIBLE ALARM. NO PT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LTV | VENTILATOR, CONTINUOUS / CBK | CBK | CAREFUSION 203, INC | LTV 900 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |