FDA Adverse Event
Injury
Summary report: N
840 VENTILATOR
MDR report key: 4151761
·
Received October 8, 2014
Report
- Report Number
- 8020893-2014-02317
- Event Type
- Injury
- Date Received
- October 8, 2014
- Report Date
- September 19, 2014
- Manufacturer
- COVIDIEN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, 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 REPLACED THE GRAPHIC USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB), GUI TO BREATH DELIVERY (BD) CABLE, AND UPGRADED THE SOFTWARE TO THE CURRENT REVISION, WHICH RESOLVED THE REPORTED ISSUE. THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND IT WAS OBSERVED TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS. COVIDIEN REFERENCE # (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, DURING PATIENT USE, THE 840 VENTILATOR GRAPHIC USER INTERFACE (GUI) HAD A COMMUNICATION MALFUNCTION WITH THE BREATH DELIVERY UNIT (BDU). THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632959 | 840 VENTILATOR | CONTINUOUS VENTILATOR | CBK | COVIDIEN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |