FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3894151
·
Received February 6, 2014
Report
- Report Number
- 8020893-2014-00291
- Event Type
- Malfunction
- Date Received
- February 6, 2014
- Report Date
- January 2, 2014
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE BACKLIGHT INVERTER PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED CALIBRATIONS, EXTENDED SELF-TEST AND SHORT SELF-TEST. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 840 VENTILATOR HAD A BLANK SCREEN. THE DEVICE WAS NOT IN USE ON A PATIENT WHEN THE MALFUNCTION OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78406 | 840 VENTILATOR | CBK; VENTILATOR, CONTINUOUS, FACILITY USE | CBK | COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |