FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3960692
·
Received June 9, 2014
Report
- Report Number
- 8020893-2014-01378
- Event Type
- Malfunction
- Date Received
- June 9, 2014
- Date of Event
- January 1, 2014
- Report Date
- May 13, 2014
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR PURITAN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) HAS NOT EVALUATED THE 840 VENTILATOR YET. UPON COMPLETION OF THE INVESTIGATION AND REPAIR, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE RESULTS. COVIDIEN REFERENCE # (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY A CUSTOMER IN THE USA THAT AN 840 VENTILATOR STOPPED CYCLING. THERE WAS NO REPORT OF PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 333595 | 840 VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR PURITAN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |