FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3193216
·
Received June 25, 2013
Report
- Report Number
- 8020893-2013-01364
- Event Type
- Malfunction
- Date Received
- June 25, 2013
- Date of Event
- January 1, 2013
- Report Date
- June 18, 2013
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AN 840 VENTILATOR HAD AN ERRATIC GUI DISPLAY. NO PT INVOLVEMENT. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE GRAPHIC USER INTERFACE CPU PCB, GUI COMMS LCD PANEL, AND BACKLIGHT INVERTER PCBS. THE UNIT PASSED EXTENDED SELF-TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 287263 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |