FDA Adverse Event
Death
Summary report: N
VOLUME VENTILATOR
MDR report key: 1695199
·
Received May 19, 2010
Report
- Report Number
- 8020893-2010-00259
- Event Type
- Death
- Date Received
- May 19, 2010
- Date of Event
- February 26, 2010
- Report Date
- April 19, 2010
- Manufacturer
- NELLCOR PURITAN BENNETT
- Product Code
- CBK
- PMA / PMN Number
- K990177
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
RECEIVED INFO STATING PT HAD EXPIRED WHILE ON ACHIEVA VENTILATOR. PT'S FAMILY ALLEGED UNIT DID NOT ALARM AT THE TIME OF EVENT. UNIT HAS BEEN EVALUATED BY THE (B) (4) COMPANY AS WELL AS BY NELLCOR PURITAN BENNETT. THE UNIT WAS FOUND TO BE AUDIO AND VISUALLY ALARMING. RESULTS INDICATE UNIT WAS WORKING ACCORDING TO SPECIFICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VOLUME VENTILATOR | VENTILATOR | CBK | NELLCOR PURITAN BENNETT | ACHIEVA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |