FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3831834
·
Received March 8, 2014
Report
- Report Number
- 8020893-2014-00569
- Event Type
- Malfunction
- Date Received
- March 8, 2014
- Date of Event
- January 1, 2014
- Report Date
- February 7, 2014
- Manufacturer
- COVIDIEN, FORMERLY NELLCO
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND REPLACED THE POWER SUPPLY. THE DEVICE PASSED ALL TESTING. (B)(4).
Description of Event or Problem · 1
COVIDIEN RECEIVED INFORMATION THAT THE 840 VENTILATOR WAS INOPERABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 141581 | 840 VENTILATOR | CBK: VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCO | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |