FDA Adverse Event
Injury
Summary report: N
840 VENTILATOR
MDR report key: 4863930
·
Received June 23, 2015
Report
- Report Number
- 8020893-2015-00593
- Event Type
- Injury
- Date Received
- June 23, 2015
- Report Date
- May 29, 2015
- Manufacturer
- COVIDIEN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED TO HAVE REPLACED THE GRAPHIC USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB). THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) WAS CALLED TO DOWNLOAD THE SOFTWARE ONTO THE CUSTOMER PURCHASED GUI PCB. THE VENTILATOR THEN PASSED ALL TESTS, CALIBRATIONS AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT, DURING PATIENT USE, A VENTILATOR BECAME INOPERATIVE. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR WITHOUT HARM. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 405027 | 840 VENTILATOR | CONTINUOUS VENTILATOR | CBK | COVIDIEN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |