FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 4153022
·
Received October 8, 2014
Report
- Report Number
- 8020893-2014-02310
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Report Date
- September 10, 2014
- Manufacturer
- COVIDIEN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE MALFUNCTION. THE CSE REPLACED THE GRAPHIC USER INTERFACE (GUI) AND BREATH DELIVERY (BD) CABLE AND THE GUI PRITED CIRCUIT BOARD (PCB). WHICH RESOLVED THE REPORTED ISSUE. THE CSE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.(B)(4)
Description of Event or Problem · 1
COVIDIEN RECEIVED INFORMATION STATING THAT AN 840 VENTILATOR HAD A LOSS OF COMMUNICATION BETWEEN THE GRAPHIC USER INTERFACE (GUI) AND THE BREATH DELIVERY UNIT (BDU). THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE MALFUNCTION OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632148 | 840 VENTILATOR | CONTINUOUS VENTILATOR | CBK | COVIDIEN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |