FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3822870
·
Received February 5, 2014
Report
- Report Number
- 8020893-2014-00199
- Event Type
- Malfunction
- Date Received
- February 5, 2014
- Date of Event
- January 20, 2014
- Report Date
- January 20, 2014
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) WAS NOT ABLE TO DUPLICATE THE ALLEGED MALFUNCTION. THE UNIT PASSED EXTENDED SELF-TESTING.
Description of Event or Problem · 1
COVIDIEN RECEIVED INFO THAT THE 840 VENTILATOR WAS INOPERATIVE. THE VENTILATOR WAS NOT IN USE ON A PT AT THE TIME THE MALFUNCTION OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76366 | 840 VENTILATOR | CBK: VENTILATOR, CONTINUOUS, FACILITY USE | CBK | COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |