FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 4001211
·
Received July 8, 2014
Report
- Report Number
- 8020893-2014-01607
- Event Type
- Malfunction
- Date Received
- July 8, 2014
- Date of Event
- January 1, 2014
- Report Date
- June 10, 2014
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH THE CUSTOMER OVER THE PHONE. THE CUSTOMER REPORTED THAT THEIR EVALUATION DETERMINED THAT THE OXYGEN SENSOR WAS CRACKED ALONG THE THREADS. TSE RECOMMENDED REPLACEMENT OF THE OXYGEN SENSOR. THE CUSTOMER REPORTED TO HAVE REPLACED THE OXYGEN SENSOR, PERFORMED ALL CALIBRATIONS AND THE DEVICE PASSED EXTENDED SELF TESTING. COVIDIEN REFERENCE: (B)(4).
Description of Event or Problem · 1
COVIDIEN RECEIVED INFORMATION STATING THAT PRIOR TO PATIENT USE A HUGE LEAK WAS HEARD ON AN 840 VENTILATOR. THE SERIAL NUMBER FOR THE DEVICE WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 395759 | 840 VENTILATOR | CONTINUOUS VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |