FDA Adverse Event
Death
Summary report: N
ESPRIT VENTILATOR
MDR report key: 4359643
·
Received December 19, 2014
Report
- Report Number
- 2031642-2014-01689
- Event Type
- Death
- Date Received
- December 19, 2014
- Date of Event
- December 8, 2014
- Report Date
- December 8, 2014
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- CBK
- PMA / PMN Number
- K981072
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- 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
THE CUSTOMER REPORTED THE DEVICE DID NOT DELIVER OXYGEN TO THE PATIENT, WHICH RESULTED IN A PATIENT DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 836728 | ESPRIT VENTILATOR | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS CALIFORNIA, INC. | V1000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Death |