FDA Adverse Event
Injury
Summary report: N
840 VENTILATOR
MDR report key: 3240291
·
Received July 18, 2013
Report
- Report Number
- 8020893-2013-01634
- Event Type
- Injury
- Date Received
- July 18, 2013
- Date of Event
- January 1, 2013
- Report Date
- June 19, 2013
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFORMATION STARTING THAT DUE TO A VENTILATOR MALFUNCTION PATIENT WAS PLACED ON A SECOND VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE. THE CUSTOMER REPORTED TO HAVE FOUND LEAK IN HUMIDIFIER TUBING. THE VENTILATOR PASSED ALL TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 333265 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |