FDA Adverse Event
Injury
Summary report: N
VELA VENTILATOR
MDR report key: 6248371
·
Received January 12, 2017
Report
- Report Number
- 2021710-2017-05208
- Event Type
- Injury
- Date Received
- January 12, 2017
- Date of Event
- October 24, 2016
- Report Date
- May 30, 2017
- 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
RESULTS OF INVESTIGATION: CAREFUSION FAILURE ANALYSIS LAB TECHNICIAN WAS ABLE TO VERIFY AND DUPLICATE THE CUSTOMER'S REPORTED ISSUE. THE PT802 TRANSDUCER WAS SUCCESSFULLY CALIBRATED, BUT THE ODV WAS AT THE MAXIMUM SPECIFICATION. ALSO THE 0 CMH2O = 690 CALIBRATION COUNT WAS 690 WHICH IS THE MAXIMUM ALLOWABLE VALUE.
Additional Manufacturer Narrative · 1
IN THE EVENT THE DEVICE IS RECEIVED FOR EVALUATION OR ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME, CAREFUSION HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FROM THE CUSTOMER FOR EVALUATION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING PATIENT USE THE VENTILATOR ALARMED TRANSDUCER FAULT. THE VENTILATOR WAS TAKEN OFF THE PATIENT AND THERE WAS NO HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30703 | VELA VENTILATOR | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | CAREFUSION, INC | VELA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |