FDA Adverse Event
Injury
Summary report: N
840 VENTILATOR
MDR report key: 3201697
·
Received June 28, 2013
Report
- Report Number
- 8020893-2013-01419
- Event Type
- Injury
- Date Received
- June 28, 2013
- Date of Event
- May 31, 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
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
COVIDIEN REC'D 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) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE BREATH DELIVERY UNIT (BDU) CPU PCB AND UPGRADED THE SOFTWARE TO THE CURRENT REVISION. THE UNIT PASSED EXTENDED SELF-TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 296969 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |