FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3201984
·
Received June 27, 2013
Report
- Report Number
- 8020893-2013-01405
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Date of Event
- January 1, 2013
- Report Date
- May 28, 2013
- Manufacturer
- COVIDIEN, FORMERLY NELLCO
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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 STOPPED CYCLING. NO PT INVOLVEMENT. COVIDIEN TECH SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH CUSTOMER OVER THE PHONE AND SUGGESTED REPLACING THE OXYGEN FLOW SENSOR TO ISOLATE THE PROBLEM. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291886 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCO | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |