FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3130274
·
Received May 22, 2013
Report
- Report Number
- 8020893-2013-01127
- Event Type
- Malfunction
- Date Received
- May 22, 2013
- Date of Event
- April 19, 2013
- Report Date
- April 23, 2013
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE EVALUATION OF THE DEVCIE HAS NOT BEEN COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AN 840 VENTILATOR HAD A BLANK SCREEN WHILE IN USE ON A PATIENT. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 227252 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |