FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3210157
·
Received July 3, 2013
Report
- Report Number
- 8020893-2013-01515
- Event Type
- Malfunction
- Date Received
- July 3, 2013
- Date of Event
- June 3, 2013
- Report Date
- June 5, 2013
- Manufacturer
- COVIDIEN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, 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 WAS INOPERABLE. NO PATIENT INVOLVEMENT. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) CPU PCB. THE UNIT PASSED EXTENDED SELF-TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 305084 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |