FDA Adverse Event
Injury
Summary report: N
VELA VENTILATOR
MDR report key: 5998494
·
Received October 4, 2016
Report
- Report Number
- 2021710-2016-04551
- Event Type
- Injury
- Date Received
- October 4, 2016
- Date of Event
- May 11, 2016
- Report Date
- September 5, 2016
- Manufacturer
- CAREFUSION, INC
- Product Code
- CBK
- PMA / PMN Number
- K093094
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). RESULTS OF INVESTIGATION: THE FAILURE ANALYSIS LAB RECEIVED THE MAIN PRINTED CIRCUIT BOARD ASSEMBLY FOR EVALUATION WHERE THE REPORTED EVENT WAS REPRODUCED AND ISOLATED TO A FAULTY TRANSDUCER ON THE CIRCUIT BOARD. THIS FAILURE IS PART OF AN INTERNAL INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER STATED THAT THIS UNIT HAD A TRANSDUCER FAULT WHILE ON A PATIENT. THERE WAS NO HARM TO THE PATIENT AT THE TIME OF THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 650314 | VELA VENTILATOR | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | CAREFUSION, INC | VELA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |