FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3210166
·
Received July 3, 2013
Report
- Report Number
- 8020893-2013-01517
- Event Type
- Malfunction
- Date Received
- July 3, 2013
- Date of Event
- January 1, 2013
- Report Date
- June 7, 2013
- Manufacturer
- COVIDIEN
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AN 840 VENTILATOR HAD AN ERRATIC GUI DISPLAY. THERE WAS NO PATIENT INVOLVEMENT. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE. THE CSE UPGRADED THE GRAPHICAL USER INTERFACE (GUI) DISPLAY FROM 9.4 TO 10.4. THE UNIT PASSED EXTENDED SELF-TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 305085 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |