FDA Adverse Event
Injury
Summary report: N
CAREFUSION
MDR report key: 4377177
·
Received December 17, 2014
Report
- Report Number
- 2021710-2014-00099
- Event Type
- Injury
- Date Received
- December 17, 2014
- Date of Event
- November 28, 2014
- Report Date
- December 1, 2014
- Manufacturer
- CAREFUSION
- Product Code
- CBK
- PMA / PMN Number
- K073069
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER EVALUATED THE VENTILATOR AND IS REPLACING THE GAS DELIVERY ENGINE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHILE IN PT USE THE VENTILATOR STOPPED VENTILATING AND WAS AUDIBLY ALARMING. THE PT WAS PLACED ON ANOTHER VENTILATOR, NO PT HARM. VENT SETTINGS: NEO MODE, PRESSURE SIMV, RATE 25, INSP PRESSURE 10, PEEP 5, PSVC 10, ITIME .65, FIO2 40%.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 830166 | CAREFUSION | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | CAREFUSION | AVEA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |