FDA Adverse Event
Injury
Summary report: N
840 VENTILATOR
MDR report key: 4092336
·
Received August 19, 2014
Report
- Report Number
- 8020893-2014-02075
- Event Type
- Injury
- Date Received
- August 19, 2014
- Report Date
- August 11, 2014
- Manufacturer
- COVIDIEN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE UNIT IS EXPECTED TO BE RETURNED FOR AN EVALUATION AND REPAIR. HOWEVER, IT HAS NOT YET BEEN RECEIVED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, DURING PATIENT USE, THE 840 VENTILATOR GENERATED A DEVICE ALERT, AND BECAME INOPERATIVE. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 500271 | 840 VENTILATOR | CONTINUOUS VENTILATOR | CBK | COVIDIEN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |