FDA Adverse Event
Injury
Summary report: N
840 VENTILATOR
MDR report key: 3201696
·
Received June 28, 2013
Report
- Report Number
- 8020893-2013-01422
- Event Type
- Injury
- Date Received
- June 28, 2013
- Date of Event
- June 3, 2013
- Report Date
- June 3, 2013
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHILE IN USE ON A PT THE 840 VENTILATOR HAD AN INOPERATIVE UPPER GUI SCREEN. THE PT INFO WAS NOT REPORTED. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE GRAPHIC USER INTERFACE CPU PCB AND BACKLIGHT INVERTER PCBS. THE UNIT PASSED EXTENDED SELF-TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 296715 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |