FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 2926545
·
Received January 17, 2013
Report
- Report Number
- 8020893-2013-00142
- Event Type
- Malfunction
- Date Received
- January 17, 2013
- Date of Event
- December 28, 2012
- Report Date
- December 28, 2012
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR PURITAN
- 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 AN 840 VENTILATOR HAD A BLANK SCREEN. COVIDIEN WAS NOT AUTHORIZED TO REPAIR THE UNIT. THE CUSTOMER REPORTED TO HAVE REPLACED THE GRAPHIC USER INTERFACE (GUI) PCB. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) UPDATED THE SOFTWARE AND CONDUCTED FINAL TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26830 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR PURITAN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |