FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3181963
·
Received June 17, 2013
Report
- Report Number
- 8020893-2013-01335
- Event Type
- Malfunction
- Date Received
- June 17, 2013
- Date of Event
- January 1, 2013
- Report Date
- May 21, 2013
- Manufacturer
- COVIDIEN, FORMERLY NELLCO
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
COVIDIEN REC'D INFO STATING THAT DUE TO A MALFUNCTION OF AN 840 VENTILATOR THE PT WAS PLACED ON A SECOND VENTILATOR. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE INSPIRATORY MODULE. THE UNIT PASSED EXTENDED SELF-TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273484 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCO | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |