FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 2925271
·
Received January 17, 2013
Report
- Report Number
- 8020893-2013-00121
- Event Type
- Malfunction
- Date Received
- January 17, 2013
- Date of Event
- December 20, 2012
- Report Date
- December 20, 2012
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT
- 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 THE 840 VENTILATOR HAD A BLANK DISPLAY. NO PT INVOLVEMENT. CUSTOMER REPORTED THAT THEY WILL REPLACE THE BACKLIGHT INVERTER PCB. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26455 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |