FDA Adverse Event
Injury
Summary report: N
CAREFUSION
MDR report key: 4377196
·
Received December 17, 2014
Report
- Report Number
- 2021710-2014-00097
- Event Type
- Injury
- Date Received
- December 17, 2014
- Date of Event
- December 4, 2014
- Report Date
- December 4, 2014
- Manufacturer
- CAREFUSION
- Product Code
- CBK
- PMA / PMN Number
- K032451
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CAREFUSION FIELD SERVICE TECHNICIAN EVALUATED THE VENTILATOR AND WAS ABLE TO DUPLICATE THE REPORTED COMPLAINT. THE TECHNICIAN CALIBRATED THE EXHALATION FLOW TRANSDUCER, PERFORMED EXHALATION VALVE RECATHETERIZATION, AND REPLACED THE EXHALATION VALVE DIAPHRAGM. THE VENTILATOR PERFORMED TO SPECIFICATIONS.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE VENTILATOR WAS STACKING BREATHS SO THEY REMOVED IT FROM THE PT AND PLACED ANOTHER VENTILATOR ON THE PT. THEY WAS NO HARM TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 830237 | CAREFUSION | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | CAREFUSION | VELA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention | NI/NI |