FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3772020
·
Received December 30, 2013
Report
- Report Number
- 8020893-2013-03291
- Event Type
- Malfunction
- Date Received
- December 30, 2013
- Date of Event
- January 1, 2013
- Report Date
- December 13, 2013
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR PURITAN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
COVIDIEN RECEIVED INFORMATION STATING THAT THE GRAPHIC USER INTERFACE (GUIL) AUDIO ERROR MESSAGE ON AN 840 VENTILATOR. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE MALFUNCTION OCCURRED. COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH THE CUSTOMER OVER THE PHONE. TSE RECOMMENDED REPLACING THE GUI ALARM. THE CUSTOMER REPORTED THAT THE ALARM CABLE WAS LOOSE AND THAT THE CONNECTION WAS RE-SOLDERED AND THE UNIT PASSED ALL TESTS. COVIDIEN WAS NOT AUTHORIZED TO REPAIR THE UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 680869 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR PURITAN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |