FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3101589
·
Received May 3, 2013
Report
- Report Number
- 8020893-2013-00993
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Date of Event
- March 11, 2013
- Report Date
- April 8, 2013
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR PURITAN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
COVIDIEN RECEIVED INFO STATING THAT DUE TO A MALFUNCTION OF AN 840 VENTILATOR THE PT WAS PLACED ON A SECOND VENTILATOR. THE CUSTOMER REPORTED TO HAVE REPLACED THE OXYGEN SENSOR. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 195042 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR PURITAN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |