FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 4071907
·
Received August 4, 2014
Report
- Report Number
- 8020893-2014-01973
- Event Type
- Malfunction
- Date Received
- August 4, 2014
- Date of Event
- January 1, 2014
- Report Date
- July 24, 2014
- Manufacturer
- COVIDIEN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE USER FACILITY REPORTED TO HAVE REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB).). THE CUSTOMER SERVICE ENGINEER (CSE) UPGRADED THE SOFTWARE TO THE CURRENT REVISION. DURING A F/U WITH THE USER FACILITY, IT WAS FOUND THAT THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO CLINICAL USE WITHOUT ISSUE. (B)(4).
Description of Event or Problem · 1
COVIDIEN RECEIVED INFO STATING THAT AN 840 VENTILATOR HAD AN ERRATIC DISPLAY. THE VENTILATOR WAS NOT IN USE ON A PT AT THE TIME THE MALFUNCTION OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 455136 | 840 VENTILATOR | CONTINUOUS VENTILATOR | CBK | COVIDIEN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |