FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3140017
·
Received May 29, 2013
Report
- Report Number
- 8020893-2013-01159
- Event Type
- Malfunction
- Date Received
- May 29, 2013
- Date of Event
- April 5, 2013
- Report Date
- May 1, 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).
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE 840 VENTILATOR HAD A BLANK DISPLAY WHILE IN USE ON A PATIENT. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE EVALUATION OF THE DEVICE HAS NOT BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 233732 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |