FDA Adverse Event
Malfunction
Summary report: N
LTV
MDR report key: 2904102
·
Received November 29, 2012
Report
- Report Number
- 2031702-2012-00304
- Event Type
- Malfunction
- Date Received
- November 29, 2012
- Date of Event
- October 10, 2012
- Report Date
- November 29, 2012
- Manufacturer
- CAREFUSION 203, INC.
- Product Code
- CBK
- PMA / PMN Number
- K051767
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VENTILATOR SHUT DOWN WITH AN AUDIBLE ALARM WHILE ON A PT. THE VENTILATOR STARTED BACK UP AND THEN SHUT DOWN ON THE PT AGAIN. NO PT HARM REPORTED. THE CUSTOMER TESTED THE VENTILATOR AND IT PASSED ALL TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LTV | VENTILATOR, CONTINUOUS/CBK | CBK | CAREFUSION 203, INC. | LTV 1000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR |