FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3983154
·
Received July 3, 2014
Report
- Report Number
- 8020893-2014-01587
- Event Type
- Malfunction
- Date Received
- July 3, 2014
- Report Date
- June 6, 2014
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR PURITAN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED TE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB). THE CSE UPGRADED THE SOFTWARE TO THE CURRENT REVISION AND PERFORMED THE EXTENDED SELF-TEST (EST), SHORT SELF-TEST (SST) AND THE PERFORMANCE VERIFICATION TEST (PVT); TE DEVICE OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS. COVIDIEN REFERENCE: (B)(4).
Description of Event or Problem · 1
COVIDIEN RECEIVED INFORMATION STATING THAT AN 840 VENTILATOR HAD A BLANK DISPLAY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE MALFUNCTION OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 392382 | 840 VENTILATOR | CONTINUOUS VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR PURITAN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |