FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3962667
·
Received June 18, 2014
Report
- Report Number
- 8020893-2014-01428
- Event Type
- Malfunction
- Date Received
- June 18, 2014
- Date of Event
- March 12, 2014
- Report Date
- May 20, 2014
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR PURITAN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE EVAL AND REPAIR OF THE DEVICE HAS NOT BEEN COMPLETED. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4). THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS
Description of Event or Problem · 1
A CUSTOMER JAPAN REPORTED THAT AN 840 VENTILATOR DISPLAY WENT DIM, AND THE VENTILATOR STOPPED CYCLING. 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 |
|---|---|---|---|---|---|---|---|
| 356685 | 840 VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR PURITAN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |