FDA Adverse Event
Injury
Summary report: N
840 VENTILATOR
MDR report key: 3201670
·
Received June 28, 2013
Report
- Report Number
- 8020893-2013-01404
- Event Type
- Injury
- Date Received
- June 28, 2013
- Date of Event
- May 11, 2013
- Report Date
- May 30, 2013
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, 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 WAS INOPERABLE WHILE IN USE ON A PT. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE CUSTOMER REPLACED THE GRAPHIC USER INTERFACE CPU PCB. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND UPGRADED THE SOFTWARE TO THE CURRENT REVISION. THE UNIT PASSED EXTENDED SELF TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 297223 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |