FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 2110001
·
Received April 28, 2011
Report
- Report Number
- 8020893-2011-00204
- Event Type
- Malfunction
- Date Received
- April 28, 2011
- Date of Event
- March 14, 2011
- Report Date
- March 29, 2011
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
COVIDIEN RECEIVED INFORMATION ALLEGING THAT, WHILE NURSE WAS IN THE ROOM WITH PATIENT, VENTILATOR SHUT DOWN. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE CUSTOMER SERVICE ENGINEER (CSE) REPLACED THE ANALOG INTERFACE PCB, POWER SWITCH AND THE GUI CABLE AS PRECAUTIONARY. FAILURE INVESTIGATION IS ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |