FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3070549
·
Received April 17, 2013
Report
- Report Number
- 8020893-2013-00883
- Event Type
- Malfunction
- Date Received
- April 17, 2013
- Date of Event
- March 18, 2013
- Report Date
- March 21, 2013
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR PURITAN
- 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 SERVICE REPORT SHOWS THE CUSTOMER REPORTED THAT THE 840 VENTILATOR HAD A BLANK SCREEN WHILE IN USE ON A PT. THERE WAS NO PT HARMED OR INJURED AS A RESULT OF THE EVENT. 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 |
|---|---|---|---|---|---|---|---|
| 165413 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR PURITAN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |