FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3101598
·
Received May 3, 2013
Report
- Report Number
- 8020893-2013-00990
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Date of Event
- April 8, 2013
- Report Date
- April 8, 2013
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR PURITAN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- 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 I40 VENTILATOR THE PT WAS PLACED ON A SECOND VENTILATOR. THE PATIENT 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 GRAPHIC USER INTERFACE (GUI) CPU PCB. THE UNIT PASSED EXTENDED SELF-TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 195043 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR PURITAN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |