FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 2102916
·
Received May 4, 2011
Report
- Report Number
- 8020893-2011-00218
- Event Type
- Malfunction
- Date Received
- May 4, 2011
- Date of Event
- February 16, 2011
- Report Date
- April 14, 2011
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 840 VENTILATOR STOPPED CYCLING. IT IS UNK IF THERE WAS PT INVOLVEMENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GET PT INFO BUT NO CUSTOMER RESPONSE. THE PURITAN BENNETT CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE BDU PCB. THE UNIT PASSED EXTENDED SELF TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |