FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3980973
·
Received July 24, 2014
Report
- Report Number
- 8020893-2014-01784
- Event Type
- Malfunction
- Date Received
- July 24, 2014
- Date of Event
- January 1, 2014
- Report Date
- July 2, 2014
- Manufacturer
- COVIDIEN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THE ISSUE WITH THE CUSTOMER OVER THE PHONE. THE CUSTOMER WAS ADVISED TO SWAP THE POWER SUPPLY. (B)(4).
Description of Event or Problem · 1
COVIDIEN RECEIVED INFORMATION OF 840 VENTILATOR WITH A BLANK DISPLAY. THE MALFUNCTION DID NOT OCCUR DURING PATIENT USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 435113 | 840 VENTILATOR | CONTINUOUS VENTILATOR | CBK | COVIDIEN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |