FDA Adverse Event
Injury
Summary report: N
840 VENTILATOR
MDR report key: 3201682
·
Received June 28, 2013
Report
- Report Number
- 8020893-2013-01447
- Event Type
- Injury
- Date Received
- June 28, 2013
- Date of Event
- January 1, 2013
- Report Date
- May 31, 2013
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
COVIDIEN RECEIVED INFO STATING THAT DUE TO A MALFUNCTION OF AN 840 VENTILATOR THE PT WAS PLACED ON A SECOND VENTILATOR. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) WAS NOT ABLE TO DUPLICATE THE ALLEGED MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE LIQUID CRYSTAL DISPLAY (LCD) PANEL AND FLEX CIRCUIT AS A PRECAUTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 297225 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |