FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3853185
·
Received April 3, 2014
Report
- Report Number
- 8020893-2014-00807
- Event Type
- Malfunction
- Date Received
- April 3, 2014
- Report Date
- March 7, 2014
- Manufacturer
- COVIDIEN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE CUSTOMER REPORTED ISSUE. THE CSE PLACED THE GRAPHIC USER INTERFACE (GUI) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). THE SOFTWARE WAS UPDATED FROM AA TO AK LEVEL. THE VENTILATOR PASSED CALIBRATIONS, EXTENDED SELF-TESTING (EST), SHORT SELF-TESTS (SST) AND FULL PERFORMANCE VERIFICATION TESTING (PVT). COVIDIEN REF: (B)(4).
Description of Event or Problem · 1
A REPORT RECEIVED FROM THE USA STATED AN 840 VENTILATOR EXPERIENCED AN ERRATIC DISPLAY. THERE WAS NO PT INVOLVEMENT AT THE TIME THE EVENT OCCURRED. THE DATE OF THE EVENT IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203048 | 840 VENTILATOR | CBK | COVIDIEN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |