FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3012872
·
Received March 1, 2013
Report
- Report Number
- 8020893-2013-00489
- Event Type
- Malfunction
- Date Received
- March 1, 2013
- Date of Event
- February 6, 2013
- Report Date
- February 6, 2013
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 840 VENTILATOR HAD AN ERRATIC DISPLAY. THERE WAS NO PT INVOLVEMENT. THE CUSTOMER REPORTED TO HAVE REPLACED THE GRAPHICAL USER INTERFACE (GUI) CPU PCB. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) WAS ONLY AUTHORIZED TO UPLOAD THE SOFTWARE. THE VENTILATOR PASSED ALL TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 90153 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |