FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3901862
·
Received May 7, 2014
Report
- Report Number
- 8020893-2014-01117
- Event Type
- Malfunction
- Date Received
- May 7, 2014
- Report Date
- April 14, 2014
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB), THE (GUI) TO BREATH DELIVERY (BD) CABLE, THE BACKLIGHT INVERTER (PCB), AND UPGRADE PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS. (B)(4).
Description of Event or Problem · 1
A REPORT REC'D FROM THE USA STATED AN 840 VENTILATOR EXPERIENCED AN ERRATIC DISPLAY. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. THE DATE OF THE EVENT IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 276914 | 840 VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |