FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 2961103
·
Received January 30, 2013
Report
- Report Number
- 8020893-2013-00237
- Event Type
- Malfunction
- Date Received
- January 30, 2013
- Date of Event
- January 17, 2013
- Report Date
- January 18, 2013
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 840 VENTILATOR HAD A BLANK SCREEN. THERE WAS NO PATIENT INVOLVEMENT. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) PCB. THE UNIT PASSED EXTENDED SELF-TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 41282 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |