FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 2781938
·
Received October 5, 2012
Report
- Report Number
- 8020893-2012-00877
- Event Type
- Malfunction
- Date Received
- October 5, 2012
- Date of Event
- September 12, 2012
- Report Date
- September 12, 2012
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 840 VENTILATOR HAD AN ERRATIC SCREEN. THERE WAS NO PT INVOLVEMENT. THE CUSTOMER REPORTED TO HAVE REPLACED THE GRAPHIC USER INTERFACE (GUI) CPU PCB. THE COVIDIEN CUSTOMER SUPPORTED 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 |
|---|---|---|---|---|---|---|---|
| 1 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |