FDA Adverse Event
Death
Summary report: N
V200 VENTILATOR
MDR report key: 4359632
·
Received December 19, 2014
Report
- Report Number
- 2031642-2014-01692
- Event Type
- Death
- Date Received
- December 19, 2014
- Date of Event
- December 10, 2014
- Report Date
- December 11, 2014
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- CBK
- PMA / PMN Number
- K102054
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ET
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PR#: (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
CUSTOMER REPORTED PATIENT DEATH ON DEVICE DUE TO WRONG PRESSURE AND WRONG MIXTURE OF GASSES. IT WAS REPORTED THAT THERE WAS PATIENT INVOLVEMENT WHERE PATIENT HAS DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 836592 | V200 VENTILATOR | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS CALIFORNIA, INC. | V200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Death |