FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 5091058
·
Received September 21, 2015
Report
- Report Number
- 8020893-2015-00933
- Event Type
- Malfunction
- Date Received
- September 21, 2015
- Report Date
- December 20, 2017
- Manufacturer
- COVIDIEN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE COVIDIEN CUSTOMER SERVICE ENGINEER (CSE) EVALUATED THE VENTILATOR AND VERIFIED THE CUSTOMER REPORTED MALFUNCTION. THE CSE REPLACED THE GRAPHIC USER INTERFACE (GUI) CENTRAL PROCESSING UNIT (CPU), INSTALLED NEW BACKLIGHT INVERTER PCBS, AND UPLOADED THE LATEST SOFTWARE REVISION. THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND WAS FOUND TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS.
Additional Manufacturer Narrative · 1
THE DEVICE WAS REPAIRED AND THE REPORTED ISSUE WAS ISOLATED TO INTERFACE BETWEEN THE DEVICE AND THE FAILED COMPONENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT, A VENTILATOR GRAPHIC USER INTERFACE (GUI) DISPLAY WAS MISSING SEGMENTS. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 622150 | 840 VENTILATOR | CONTINUOUS VENTILATOR | CBK | COVIDIEN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |