FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3897130
·
Received May 21, 2014
Report
- Report Number
- 8020893-2014-01227
- Event Type
- Malfunction
- Date Received
- May 21, 2014
- Date of Event
- January 1, 2014
- Report Date
- April 22, 2014
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
A COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) AND UPGRADED THE SOFTWARE TO THE CURRENT REVISION. THE CSE THEN PERFORMED THE EXTENDED SELF TEST (EST), THE SHORT SELF TEST (SST) AND THE PERFORMANCE VERIFICATION TEST (PVT). THE UNIT PASSED ALL TESTING. COVIDIEN REFERENCE: (B)(4).
Description of Event or Problem · 1
A REPORT WAS RECEIVED FROM THE USA STATING THAT AN 840 VENTILATOR HAD AN ERRATIC 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 |
|---|---|---|---|---|---|---|---|
| 304083 | 840 VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |