FDA Adverse Event
Injury
Summary report: N
840 VENTILATOR
MDR report key: 3201355
·
Received June 27, 2013
Report
- Report Number
- 8020893-2013-01393
- Event Type
- Injury
- Date Received
- June 27, 2013
- Date of Event
- May 24, 2013
- Report Date
- May 29, 2013
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE 840 VENTILATOR STOPPED CYCLING WHILE IN USE ON A PT. THERE WAS NO PT HARMED OR INJURES AS A RESULT OF THE EVENT. COVIDIEN WAS NOT ABLE TO DUPLICATE THE ALLEGED MALFUNCTION. COVIDIEN REPLACED THE SAFETY VALVE AS PRECAUTIONARY. THE VENTILATOR PASSED ALL TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291980 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |