FDA Adverse Event
Injury
Summary report: N
840 VENTILATOR
MDR report key: 3201377
·
Received June 27, 2013
Report
- Report Number
- 8020893-2013-01403
- Event Type
- Injury
- Date Received
- June 27, 2013
- Date of Event
- January 1, 2013
- Report Date
- May 28, 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
- MD, 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. COVIDIEN TECH SUPPORT ENGINEER (TSE) TROUBLESHOOT THIS ISSUE WITH CUSTOMER OVER THE PHONE AND SUGGESTED REPLACING THE ANALOG INTERFACE PCB OR DATA KEY TO ISOLATE THE PROBLEM. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 293696 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |