FDA Adverse Event
Injury
Summary report: N
840 VENTILATOR
MDR report key: 4092330
·
Received August 19, 2014
Report
- Report Number
- 8020893-2014-02035
- Event Type
- Injury
- Date Received
- August 19, 2014
- Date of Event
- August 1, 2014
- Report Date
- August 1, 2014
- Manufacturer
- COVIDIEN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- RESPIRATORY THERAPIST
Narratives
Additional Manufacturer Narrative · 1
THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE DEVICE, AND WAS UNABLE TO DUPLICATE THE REPORTED MALFUNCTION. THERE WERE NO ERROR CODES IN THE MEMORY LOG, AND 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 GRAPHIC USER INTERFACE (GUI) DISPLAY WAS BLANK. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 500269 | 840 VENTILATOR | CONTINUOUS, VENTILATOR | CBK | COVIDIEN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |