FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3012866
·
Received March 1, 2013
Report
- Report Number
- 8020893-2013-00498
- Event Type
- Malfunction
- Date Received
- March 1, 2013
- Date of Event
- February 7, 2013
- Report Date
- February 7, 2013
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AN 840 VENTILATOR HAD AN ERRATIC GUI DISPLAY. THE CUSTOMER REPORTED TO HAVE REPLACED THE GRAPHICAL USER INTERFACE (GUI) CPU PCB. COVIDIEN WAS NOT AUTHORIZED TO REPAIR THE UNIT. THE CSE (CUSTOMER SUPPORT ENGINEER) INSPECTED THE DEVICE AND UPGRADED THE SOFTWARE TO THE CURRENT REVISION. THE UNIT PASSED EXTENDED SELF TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 90151 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |