FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3822859
·
Received February 5, 2014
Report
- Report Number
- 8020893-2014-00219
- Event Type
- Malfunction
- Date Received
- February 5, 2014
- Date of Event
- January 8, 2014
- Report Date
- January 8, 2014
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR PURITAN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
COVIDIEN REFERENCE NUMBER: (B)(4). THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE REPORTED MALFUNCTION. THE UNIT PASSED EXTENDED SELF-TESTING.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 840 VENTILATOR HAD AN ERRATIC DISPLAY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76296 | 840 VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR PURITAN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |