FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3813521
·
Received March 26, 2014
Report
- Report Number
- 8020893-2014-00696
- Event Type
- Malfunction
- Date Received
- March 26, 2014
- Report Date
- February 24, 2014
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR PURITAN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE MALFUNCTION. THE CSE REPLACED THE GRAPHICAL USER INTERFACE (GUI) CENTRAL PROCESSING UNIT (CPU) AND UPDATED THE BACKLIGHT INVERTER PCB'S. THE UNIT PASSED EXTENDED SELF-TESTING (EST), SHORT SELF-TEST (SST), ALL CALIBRATIONS AND A PERFORMANCE VERIFICATION ACCORDING TO THE MANUFACTURER'S SPECIFICATIONS. (B)(4).
Description of Event or Problem · 1
A REPORT RECEIVED FROM THE USA STATED THAT THE LOWER HALF OF THE DISPLAY ON AN 840 VENTILATOR WAS ERRATIC. THERE WAS NO REPORT OF PT INVOLVEMENT. THE DATE OF THE EVENT IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 176912 | 840 VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR PURITAN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |