FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3983176
·
Received July 3, 2014
Report
- Report Number
- 8020893-2014-01577
- Event Type
- Malfunction
- Date Received
- July 3, 2014
- Date of Event
- January 1, 2014
- Report Date
- June 6, 2014
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THE ISSUE WITH THE CUSTOMER OVER THE TELEPHONE, AND ADVISED TO PERFORM GROUND ISOLATION TEST AND EXTENDED SELF-TESTING (EST) OVER THE WEEKEND TO DUPLICATE THE ALLEGED MALFUNCTION. THE CUSTOMER REPORTED THAT THE UNIT PASSED THE EXTENDED SELF-TEST (EST); RAN THE UNIT FOR SEVERAL DAYS ON TEST LUNG, AND WAS UNABLE TO DUPLICATE THE ISSUE. THE CUSTOMER REPORTED TO HAVE CONDUCTED FINAL TESTING. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY A CUSTOMER IN THE USA THAT AN 840 VENTILATOR DISPLAYED AN INOPERABLE ERROR. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 392335 | 840 VENTILATOR | CONTINUOUS VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |