FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3210173
·
Received July 3, 2013
Report
- Report Number
- 8020893-2013-01510
- Event Type
- Malfunction
- Date Received
- July 3, 2013
- Date of Event
- April 29, 2013
- Report Date
- June 6, 2013
- Manufacturer
- COVIDIEN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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 INOPERABLE GUI. THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER REPORTED TO HAVE REPLACED THE GRAPHIC USER INTERFACE CPU PCB. COVIDIEN WAS NOT AUTHORIZED TO REPAIR THE VENT. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE 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 |
|---|---|---|---|---|---|---|---|
| 304591 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |