FDA Adverse Event
Injury
Summary report: N
840 VENTILATOR
MDR report key: 4200752
·
Received October 24, 2014
Report
- Report Number
- 8020893-2014-02395
- Event Type
- Injury
- Date Received
- October 24, 2014
- Date of Event
- October 1, 2014
- Report Date
- October 3, 2014
- Manufacturer
- COVIDIEN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE DEVICE, AND VERIFIED THE REPORTED MALFUNCTION. THE CSE UPGRADED THE SOFTWARE TO THE CURRENT REVISION TO RESOLVE THE ISSUE. NO PARTS WERE REPLACED. THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND IT WAS OBSERVED TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS. (B)(4)..
Description of Event or Problem · 1
IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, DURING PATIENT USE, THE 840 VENTILATOR GRAPHICAL USER INTERFACE (GUI) DISPLAY WAS INOPERABLE. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 679713 | 840 VENTILATOR | CONTINUOUS VENTILATOR | CBK | COVIDIEN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |