FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3060716
·
Received April 5, 2013
Report
- Report Number
- 8020893-2013-00814
- Event Type
- Malfunction
- Date Received
- April 5, 2013
- Date of Event
- March 19, 2013
- Report Date
- March 19, 2013
- Manufacturer
- COVIDIEN, FORMERLY NELLCO
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AN 840 VENTILATOR WAS INOPERABLE WHILE IN USE ON A PT. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) CPU PCB. THE UNIT PASSED EXTENDED SELF-TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 139666 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCO | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |